HospitalInspections.org

Based on observation, interview and record review, the facility failed to protect the rights of one (#1) of two patients reviewed for as needed antipsychotic medication use resulting in the use of a chemical restraint without adequate justification with potential undesirable outcomes. Findings include:

See specific tag:

A 0160 - Based on observation, interview and record review the facility failed to ensure that a medications were not used as a chemical restraint for one (#1) of two patients reviewed for as needed antipsychotic medication administration out of seven patients reviewed for antipsychotic medication administration, resulting in the potential for antipsychotic medication side effects.

Based on observation, interview and record review the facility failed to ensure that medications were not used as a chemical restraint and that less restrictive interventions were attempted first for one (#1) of two patients reviewed for as needed antipsychotic medication administration, resulting in the potential or possible occurrence of antipsychotic medication side effects. Findings include:

On 10/9/19 at approximately 1000 Patient #1 was observed in the facility's Medical Intensive Care Unit (MICU). Patient #1 was on mechanical ventilation (artificial respiration) with a tracheostomy (surgical opening through the throat into the patient's airway for connection to the mechanical ventilator) and had a tube feeding running through a Percutaneous endostomic gastrostomy (PEG - a surgical opening through the abdomen into the patient's stomach for tube feedings). Patient #1 was alert but was only able to move his right thumb. His nurse Staff P reported that Patient #1 was diagnosed with Neuroleptic Malignant Syndrome (NMS) by his neurologist "two weeks ago" and was making gradual improvements with anti NMS medication therapy. Staff P reported that Patient #1 was now more alert and could move a little to answer "yes" or "no" to questions with thumb movements of his right hand.

On 10/10/19 at approximately 0900 Patient #1's clinical record (EMR) was reviewed and revealed the following information:

Patient #1 was an 18 year old developmentally disabled male who was brought to the facility Emergency Department (ED) by ambulance on 9/4/19 at 1553 after he ran into the road and was hit by a car. The ED physician history and physical assessment dated 9/4/19 at 1819 noted that Patient #1 had minor abrasions but no other symptoms of injury. The ED physician noted that Patient #1 had a history of schizophrenia and autism and was a poor historian. The physician documented that Patient #1 was alert and oriented (x3) and had no physical impairments. The ED physician documented that X-rays, CT scans, and other testing and evaluations revealed Patient #1 had no signs of significant physical injury from the car accident and was medically stable for discharge. Patient #1 told the ED staff that he heard voices in his head which told him to jump in front of a car, and a Psychiatrist evaluation (consult) was ordered.

The ED consultant Psychiatrist who examined Patient #1 documented that Patient #1 met criteria for involuntary inpatient psychiatric treatment and wrote the following routine (therapeutic) psychiatric medication orders for Patient #1:

1. "Risperidone (an antipsychotic medication) 1 mg (milligram) PO (by mouth) q (every) AM (morning) and q (every) HS (hour of sleep) to help with the psychosis."

2. "Ativan 0.5 mg PO TID (three times daily) to help with agitation, anxiety and restlessness."

In addition, the Psychiatrist prescribed the following psychotrophic (mind altering) medications on an as needed basis (PRN) to use if Patient #1, "experiences psychotic symptoms, refuses oral medications, is not re-directable, becomes agitated and becomes a threat to self/and/or others":

1."Haloperidol (antipsychotic medication with an Food and Drug Administration (FDA) "Black Box Warning" that warns prescribers of it's risk of causing severe potentially irreversible adverse reactions including Extrapyramidal Symptoms (EPS), dyskinesias (abnormal involuntary movements) and/or death) 3 mg IM (intramuscular injection) TID PRN for when patient experiences psychotic symptoms, refuses oral medications, is not re-directable, becomes agitated and becomes a threat to self/and/or others."

2."Ativan (lorazepam - a benzodiazepine antianxiety medication) 2 mg IM TID PRN for when patient refuses oral medications, is not re-directable, becomes agitated and becomes a threat to self/and/or others."

The Behavioral Health (BH) Unit Psychiatrist Admission assessment dated 9/10/19 at 1225 documented that Patient #1's AIMS (Abnormal Involuntary Movement Scale) test on 9/10/19 scored 0 out of 12 - no abnormal movements. (AIMS tests for abnormal involuntary movements - an often irreversible side effect of antipsychotic medications, with older types of antipsychotic medications such as Haloperidol posing the greatest risk) The Psychiatrist documented that Patient #1's muscle strength and tone were within normal limits with no abnormal involuntary movements, motor or sensory deficits. The Psychiatrist rewrote medication orders for Patient #1 on admission to the Behavioral Health (BH) (psychiatric) Unit. These included the following routine (therapeutic) antipsychotic medication:

1. Risperidone 2 mg PO (by mouth) bid,

and the following PRN psychotrophic medications:

1. Ativan 2 mg IM PRN for anxiety or agitation TID
2. Haloperidol 3 mg IM PRN for agitation

The Psychiatrist noted on his admission assessment plan dated 9/10/19 at 1225 that behavioral methods including but not limited to redirection should be used if Patient #1 was agitated or displayed psychotic symptoms, and documented that PRN medication would be used in case of severe agitation or severe psychotic symptoms if behavioral methods failed.

Review of Patient #1's PRN medication administration record revealed that Patient #1 was given injections of both of his PRN medications (Haloperidol 3 mg IM and Ativan 2 mg IM) at the same time on eight occasions without documentation of severe agitation or psychotic symptoms that posed a threat to self and or others. There was no documentation that behavioral interventions or redirection were tried first without success before these PRN injections were given. There was no documentation to explain why Haloperidol and Ativan were both given at the same time. PRN Haloperidol IM and PRN Ativan IM injections were given to Patient #1 on the following occasions without documentation that the indications for use were met:

1. 9/4/19 at 2351 - Staff U gave Patient #1 3 mg of Haloperidol and 2 mg of Ativan given IM. The only documentation for this PRN use was documented as, "Patient agitated, hyperverbal, stating that he sees demons that are coming to get him."

2. 9/6/19 at 1634 - Staff X gave Patient #1 3 mg of Haloperidol and 2 mg of Ativan IM at the same time- The only documentation regarding PRN use was, "Agitation".

3. 9/6/19 at 2219 - Staff Y gave Patient #1 3 mg of Haloperidol and 2 mg of Ativan IM at the same time - The only documentation regarding this noted, "Patient agitated and anxious. PRN given as ordered."

4. 9/7/19 at 1416 - Staff S gave Patient #1 Haloperidol 3 mg IM and Ativan 2 mg IM at the same time for, "patient (pt) is anxious and focused on discharge".

5. 9/7/19 at 1832 - Staff S gave Patient #1 Haloperidol 3 mg IM and Ativan 2 mg IM at the same time for, "patient (pt) is anxious, approaching nursing station multiple times, intrusive, focused on discharge and requesting medication to sleep."

6. 9/8/19 at 2002 - Staff T gave 3 mg of Haloperidol and 2 mg of Ativan IM given at the same time - The only documentation for this PRN use was, "Pt is anxious, pacing, verbal argument with another patient."

7. 9/9/19 at 2347 - Staff U gave 3 mg of Haloperidol and 2 mg of Ativan IM at the same time - the reason for PRN use was left blank (not documented). There was no documentation for this PRN use.

8. 9/10/19 at 2211 - Staff V gave Patient #1 3 mg of Haloperidol and 2 mg of Ativan IM at the same time - The only documentation for this PRN use was, "restless, pacing."

On 10/10/19 at approximately 1200 Staff H and Staff I were asked why an Haloperidol PRN injection was given on each of these occasions, as there was no documentation of severe agitation or of any attempts to redirect his behavior or use of less restrictive interventions. These staff were unable to explain why both Ativan and Haloperidol were administered at the same time, or why they were documented as given for anxiety and/or restlessness or when the patient asked for a sleeping medication (hypnotic). Staff I stated that the lack of Nursing documentation for PRN Haloperidol use, and for why both Ativan and Haloperidol were given at the same time was, "not what is expected."Staff H and Staff I were asked whether the documentation indicated that the Haloperidol was used as a chemical restraint for staff convenience because Patient #1 was "intrusive" or was not staying in his room. They were also asked why Haloperidol was given on 9/7/19 at 1832 as it was not an anti-anxiety medication or a hypnotic (sleeping pill) and it was not bedtime (HS). Staff I said that the nurse did not document well and said that she would have liked to see a note indicating that behavioral interventions were tried, and the patient could not be calmed or redirected.

There was no additional Nursing or Physician documentation provided when requested to indicate that Patient #1 was given Haloperidol for severe un-redirectable agitation, or that behavioral interventions, antianxiety medications (Ativan IM) or less restrictive interventions were tried unsuccessfully before IM haloperidol was given. There was no documentation to indicate that Patient #1 posed a threat to self or others while admitted.

Review of Patient #1's clinical record revealed he was seen by the Rapid Response team on 9/12/19 at 1412 for an episode of unresponsiveness and vomiting. A "Code Blue" (emergency resuscitation event) was called for Patient #1 on 9/14/19 at 0100 because Patient #1 was unresponsive. Patient #1 was transferred to a medical floor for closer observation. A Rapid Response Team note dated 9/17/19 at 0855 noted that Patient #1 was intubated (breathing tube inserted) and placed on mechanical ventilation (artificial respiration) and then transferred to the MICU. "Impression" was noted as Acute Respiratory Failure secondary to hypoxia from possible aspiration. MICU Physician documentation on 9/17/19 at 1552 noted that Patient #1 was intubated due to dysphagia (swallowing impairment) and inability to protect his airway due to unresponsiveness, generalized (whole body) muscle rigidity and Extra Pyramidal Symptoms (EPS - dysfunction of the involuntary/autonomic muscle control area of the brain - a side effect of antipsychotic medications, particularly the older anti-psychotic medications such as Haloperidol).

MICU documentation revealed that Patient #1 had symptoms indicative of side effects from an antipsychotic medication such as Haloperidol or (less commonly) Resperidone. A Neurology Progress Note for Patient #1 dated 9/14/19 at 1923 documented that Patient #1 had acute extra pyramidal symptoms (EPS) with significantly increased muscle tone on all limbs, rigidity, and hyperactive reflexes. The Neurologist's diagnosis was "medication induced EPS symptoms or early Neuroleptic Malignant Syndrome (NMS). Medication therapy to treat NMS (dantrolene and bromocriptine, diazepam) was started. Lumbar punctures, Electro encephalographs (EEG), spinal and brain imaging, and laboratory testing failed to rule out other causes of Patient #1's symptoms. Physician's Progress notes continued to document NMS as a presumptive diagnosis.

On 10/10/19 at 1100 the National Library of science website information on Neuroleptic Malignant Syndrome (NMS) was reviewed (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3726098/) The information included the following, "Neuroleptic Malignant Syndrome (NMS) is a life-threatening idiosyncratic reaction to antipsychotic drugs characterized by altered mental status, muscle rigidity, and autonomic dysfunction. The clinical course typically begins with muscle rigidity and mental status changes that can range from mild drowsiness, agitation, or confusion to a severe delirium or coma. Although muscle rigidity is the most frequently described motor sign, a large number of additional extrapyramidal (brain areas controlling involuntary movements) motor findings have been reported including tremor, chorea (involuntary limb jerking), akinesia (loss of voluntary movement), and dystonic movements. Other symptoms that have been associated with NMS include dysphagia (swallowing problems), dyspnea (breathing problems), abnormal reflexes, mutism (inability to speak), and seizures. The primary trigger of NMS is dopamine (neurotransmitter) receptor blockade and the standard causative agent is an antipsychotic. Potent typical neuroleptics such as haloperidol, fluphenazine, chlorpromazine, trifluoperazine, and prochlorperazine have been most frequently associated with NMS and thought to confer the greatest risk."

On 10/10/19 at 1000 review of the facility policy entitled, "Use of Psychotrophic Medications/Medication Procedures" dated 12/15/13 noted the following statement, "Medication shall not be used as punishment or for staff's convenience."

On 10/10/19 at 1010 review of the facility policy entitled, "Restraint and Seclusion use in Behavioral Health", dated 11/1/17 revealed the following statements:

"Objective: to prevent the patient from physically harming self, others or in order to prevent him or her from causing substantial property damage",

"Chemical Restraint: A drug used as a restraint is a medication used to control behavior or to restrict the patient's freedom of movement And is not a standard treatment or dosage for the patient's medical or psychiatric condition."

"Restraint or seclusion may only be used in response to emergent, dangerous behaviors as an adjunct to planned care"

"The type or technique of restraint or seclusion used must be the least restrictive intervention that will be effective to protect the patient, a staff member or others from harm"

Based on observation, interview and record review, the facility failed to ensure that the Nursing Care Planning process for patient assessment, desired outcomes and planned interventions was comprehensively implemented for one (#1) of seven patients reviewed for Nursing Care plans, out of a total sample of 10, resulting in the potential for missed care needs. Findings include:

On 10/9/19 at approximately 1000 Patient #1 was observed in the Intensive Care Unit on mechanical ventilation (artificial respiration) and tube feedings through a Percutaneous Endoscopic Gastrostomy (PEG - surgical opening directly into the stomach). Patient #1 was alert but could only move his right thumb. His nurse Staff P reported that Patient #1 was diagnosed with Neuroleptic Malignant Syndrome (NMS - an adverse effect of antipsychotic medications) by his neurologist "two weeks ago".

On 10/10/19 at approximately 0900 Patient #1's clinical record (EMR) was reviewed and revealed the following information:

Patient #1 was an 18 year old developmentally disabled male who was brought to the facility Emergency Department (ED) by ambulance on 9/4/19 at 1553 after he ran into the road and was hit by a car. The ED physician history and physical assessment dated 9/4/19 at 1819 noted that Patient #1 had minor abrasions but no other symptoms of injury. The ED physician noted that Patient #1 had command hallucinations of voices telling him to throw himself in front of a car and ordered a psychiatrist consultation. Patient #1 was held in the Behavioral Health area of the ED until an inpatient Behavioral Health (psychiatric) bed became available.

Patient #1 was admitted to the facility Behavioral Health Unit on 9/9/19. Patient #1 was ordered the following as needed (PRN) medications to treat severe agitation and or psychotic symptoms:

1. Ativan (anti-anxiety medication) 2 mg PRN (as needed) for anxiety or agitation TID
2. Haloperidol (anti-psychotic medication) 3 mg PRN for agitation

The Psychiatrist noted on a physician admission assessment treatment plan dated 9/10/19 at 1225 that behavioral methods including but not limited to redirection should be used if Patient #1 was agitated or displayed psychotic symptoms. The treatment plan documented that PRN medication would be used in case of severe agitation or severe psychotic symptoms if behavioral methods failed.

Review of Patient #1's PRN medication administration record revealed that Patient #1 was given injections of both of his PRN medications (Haloperidol 3 mg IM and Ativan 2 mg IM) at the same time on eight occasions without documentation that behavioral interventions or redirection were tried first without success before these PRN injections were given.

Review of Nursing Care Plans for Patient #1 from 9/9/19 through 9/14/19 revealed there was no Nursing Care plan for Anxiety, no Nursing care Plan for Agitation, and no Nursing Care Plan for Undesirable Behaviors or for delusions. The Nursing Care plans contained one mental health problem, which was noted as "Depression". There was no documentation of behavioral interventions or redirecting methods to be used as Nursing Interventions for symptoms of psychosis, agitation or anxiety.

On 10/10/19 at approximately 1200 Staff H and Staff I were asked why Haloperidol and Ativan PRN injections were given on eight occasions. Staff I reported that the Haloperidol must have been given because of severe agitation and anxiety. When queried at this time Staff H and Staff I reported that Nursing Care Plans were updated each shift and should include all active problems with targeted interventions to help the patient resolve the problems and should have included Anxiety, Agitation and Psychosis as active problems. When queried at this time, Staff H and Staff I were unable to provide documentation of any Nursing Care Plans with targeted Nursing Interventions related to Patient #1's documented anxiety and agitation.