HospitalInspections.org

Based on interview and record review, the facility failed to ensure that an individualized Nursing Care plan with targeted interventions was developed in a timely manner for one (#1) of one patients with psychiatric diagnoses reviewed out of a total sample of 10, resulting in the potential for provoking or exacerbating combative behaviors and ineffective management of problematic behaviors resulting in potentially avoidable physical restraint. Findings include:

On 3/26/19 at approximately 1345, Patient #1's clinical record (EMR) was reviewed with the Patient Care Director Staff B and the Director of Quality Management Staff E and the following was revealed:

Patient #1 was a 73 year old male who was admitted to the facility on 1/31/19 after a fall at home with hip fracture. Diagnoses included Left Femoral Neck Fracture secondary to fall, Facial Laceration (secondary to fall), Atrial fibrillation with Rapid Ventricular Response, Cardiac Arrhythmia - Pacemaker, Post-Traumatic Stress Disorder (PTSD), Anxiety and Depression, Lumbar Disc Disease with Radiculopathy (pinched nerve in lower spine), and Chronic Back Pain.

Admission Physician's History and Physical (H & P) examinations dated 1/31/19 at 2250 documented that Patient #1 received psychiatric treatment at the Veteran's Administration (VA) Hospital for diagnoses of Post Traumatic Stress Disorder and Depression. The H & P noted that Patient #1 had some memory impairment, a history of a previous traumatic brain injury at work, and had a likely concussion from his fall prior to admission.

A Neurology Consultant Physician documentation dated 2/5/19 at 1403 noted that Patient #1 had a history of PTSD and a prior traumatic brain injury. The Neurologist documented that Patient #1 had cognitive impairment with psychiatric features including hallucinations after his brain injury.

A Nursing Note dated 2/7/19 at 0337 noted that Patient #1 was unable to sleep and was anxious and disoriented to place and situation. There were no interventions documented in response to this.

A Nursing Note dated 2/7/19 at 0547 documented that Patient #1 attempted to go to the bathroom alone at approximately 0445 and became "very anxious, uncooperative and combative" when "stopped" by staff. The note documented that Patient #1 was yelling at staff to get out of his way and demanded a phone to call the police. The note documented that Patient #1 was trying to physically push his way out of the room when staff got him back to bed. Patient #1 was placed in bilateral arm and leg restraints on 2/7/15 at 0500. Less restrictive methods of redirection attempted before restraints were ordered was documented as "distraction/diversion", but there was no narrative description of this.

A Physician Progress Note dated 2/7/19 documented that Patient #1 was, "placed into soft restraints after attempting to swing at staff."

A review of Nursing Care Plans and daily nursing assessments and care plan interventions revealed Patient #1 revealed there was no Nursing Care Plan or interventions for Behavior/Psychiatric diagnosis until 02/07/19. This was a Nursing Care Plan for "Delusional Thought", initiated on 2/7/19 at 0938 (approximately four and 1/2 hours after Patient #1's episode of combativeness) and did not include individualized interventions to de-escalate anxiety or combative behavior.

There was no individualized Nursing Care Plan for PTSD for Patient #1 with individualized interventions and approaches identifying Patient #1's behavioral "triggers" for his PTSD (situations, people or things that might result in an increase in Patient #1's anxiety level and lead to combativeness). There were no individualized interventions or approaches to guide nursing staff in behavior management of undesirable behaviors related to Patient #1's PTSD. There were no individualized approaches that historically helped to deescalate Patient #1's anxiety and resulting combativeness related to PTSD.

On 3/27/19 at approximately 1330, Staff B was asked about individualized Nursing Care plans for Patients with Psychiatric diagnoses. Staff B stated that Nursing Care plans should be implemented as soon as possible after admission and updated daily as needed. Staff B stated that Facility Nursing Care Plans for each patient were computer generated when the Nurse activated a "problem" from a set list of Nursing Problems on the computer.

No policies for Nursing Care Plans or for protocols for behavior management were provided.

Based on interview and record review the facility failed to follow their policy and the Food and Drug Administration's approved use for haloperidol administration to one of one (#1) patients reviewed for psychiatric diagnoses out of a total sample of 10, resulting in the potential for serious side effects and adverse outcomes. Findings include:

On 3/26/19 at approximately 1345, Patient #1's clinical record (EMR) was reviewed with the Patient Care Director Staff B and the Director of Quality Management Staff E and the following was revealed:

Patient #1 was a 73 year old male who was admitted to the facility on 1/31/19 after a fall at home with hip fracture. Diagnoses included Left Femoral Neck Fracture secondary to fall, Facial Laceration (secondary to fall), Atrial fibrillation with Rapid Ventricular Response, Cardiac Arrythmia - Pacemaker, Post-Traumatic Stress Disorder (PTSD), Anxiety and Depression, and Hypothyroidism.

Patient #1's psychiatric medications prior to admission were listed as:

ARIPiprazole (Abilify) 10 milligrams (mg) dialy (qd) by mouth (PO)
BuProPion ( Wellbutrin) 12 hour (hr) release 150 mg twice dialy (bid) PO
Venlafaxine (Effexor) 24 hr release 300 mg qd PO

An Admission Physician's History and Physical (H & P) examination dated 1/31/19 at 2250 documented that Patient #1 received psychiatric treatment at the Veteran's Administration (VA) Hospital for diagnoses of Post Traumatic Stress Disorder and Depression. The H & P noted that Patient #1 had some memory impairment, a history of a previous tramautic brain injury at work, and had a likely concussion from his fall prior to admission.

A Neurology Consultant Physician documentation dated 2/5/19 at 1403, noted that Patient #1 had a history of PTSD and a prior traumatic brain injury which resulted in cognitive impairment with psychiatric features including hallucinations. The Neurologist documented that Patient #1 saw his psychiatrist at the VA regularly. The Neurologist assessment noted that Patient #1 had difficulty with short term memory recall and diminished problem solving abilities. Her assessment was "concussion secondary to mechanical fall on 1/31/19 and her plan was to continue the psychiatric medication regimen prescribed by Patient #1's psychiatrist at the VA. The Neurologist noted this medication regimen as, Abilify (an atypical antipsychotic medication), Effexor (a medication to treat anxiety, depression and panic disorders) and Bupropion (a medication to treat depression).

Physician's Progress notes dated 2/7/19 and 2/8/19 documented that Patient #1 had periodic episodes of delirium and increased confusion on 2/6 and 2/7. A Physician Progress Note dated 2/7/19 documented that Patient #1 was, "placed into soft restraints after attempting to swing at staff."

A Physician's Progress Note by Internal Medicine Resident Physician Staff Q dated 2/7/19 at 0921 documented that Patient #1 was calm, and cooperative with occasional confusion during the examination. Staff Q documented that Patient #1 received the following psychiatric medications :

ARIPiprazole (Abilify) 10 milligrams (mg) dialy (qd) by mouth (PO)
BuProPion ( Wellbutrin) 12 hour (hr) release 150 mg twice daily (bid) PO
Venlafaxine (Effexor) 24 hr release 300 mg qd PO

Staff Q wrote an order on 02/7/19 at 1229 (four hours after Staff Q's progress note) for Patient #1 to receive regular doses of Intravenous (IV) haloperidol (a conventional antipsychotic medication with a Food and Drug Administration "Black BoxWarning" that use may result in serious side effects including death). Staff Q's order for Patient #1 was noted as, "haloperidol 0.5 mg IV every six hours (Q6). ("off label" method of giving haloperidal -IV administration of haloperidal is not approved by the FDA).

A Psychiatrist consultation dated 2/9/29 documented that Patient #1 was taking ARIPiprazole (Abilify) 10 milligrams (mg) daily (qd) by mouth (PO), BuProPion ( Wellbutrin) 12 hour (hr) release 150 mg twice dialy (bid) PO and Venlafaxine (Effexor) 24 hr release 300 mg qd PO and haloperidol 0.5 mg IV q6. The Psychiatrist diagnosed Patient #1 with, "delirium due to medications/medical issues. The Psychiatrist's recommendations included a recommendation to change the routinely administered haloperidol to "as needed for agitation" (PRN) by mouth (PO) or by intramuscular injections (IM) and testing for dementia.

There is no indication that the attending physician or resident physicians noted the psychiatrist's recommendations or reevaluated the (off label) haloperidol prescription.

Patient #1 continued to receive IV haloperidol until he was transferred to the inpatient rehabilitation floor on 2/12/19, when his dose whas changed to haloperidol 0.5 mg PO (by mouth) bid.

On 3/27/19 at approximately 1000, the Pharmacy Director Staff I was interviewed and was asked about the facility policy for haloperidol use. Staff I stated, "Per our policy, it states that it should be given orally (PO) or intramuscularly (IM)." It is a "Black Box Drug (FDA warning of dangerous side effects)."This policy was requested but not provided .

On 3/27/19 at approximately 1015, Staff B provided a facility document (2018) entitled, "Intravenous (IVP) Drug List - Approved for Routine RN Administration." Review of this list revealed haloperidol is approved for Intra-muscular injection (IM) for "antipsychotic/agitation". Staff B stated that this list is posted on each nursing station and all registered nurses (RN) should know that RNs may not administer haloperidol by the intravenous route. Documentation of each IV haloperidol dose given to Patient #1 during his admission was requested but not provided for review but Staff B acknowleged that the IV haloperidol was administered to Patient #1 by RNs from 2/7/19 to 2/12/19.

On 3/27/19 at approximately 1400, the Vice President of Medical Services Staff J stated that attending physicians do not have to follow consultant physician's recommendations but they should document their evaluation and decision making if they don't. Staff J stated that the facility policy prohibiting nurses from administering haloperidol intravenously was a facility fail-safe mechanism to make sure that haloperidol was not given intravenously if a physician did order it to be given IV.

On 3/27/19 at approximately 1500, review of the U.S. Food and Drug Administration (FDA) website revealed the following warnings for haloperidol (https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/015923s082,018701s057lbl.pdf):

"Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death,

Cases of sudden death, QT-prolongation, and Torsades de Pointes (heart conduction problems resulting in dangerous cardiac arrythmias) have been reported in patients receiving HALDOL. Intravenous administration of HALDOL appears to be associated with a higher risk of QT-prolongation and Torsades de Pointes.

Particular caution is advised in treating patients with other QT-prolonging conditions, drugs known to prolong QT, underlying cardiac abnormalities, hypothyroidism,

HALDOL INJECTION IS NOT APPROVED FOR INTRAVENOUS ADMINISTRATION.

Tardive Dyskinesia: A syndrome consisting of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with antipsychotic drugs. The prevalence of the syndrome appears to be highest among the elderly,

Given these considerations, antipsychotic drugs should be prescribed in a manner that is most likely to minimize the occurrence of tardive dyskinesia. Chronic antipsychotic treatment should generally be reserved for patients who suffer from a chronic illness that, 1) is known to respond to antipsychotic drugs, and, 2) for whom alternative, equally effective, but potentially less harmful treatments are not available or appropriate. In patients who do require chronic treatment, the smallest dose and the shortest duration of treatment producing a satisfactory clinical response should be sought. The need for continued treatment should be reassessed periodically.

A number of cases of bronchopneumonia, some fatal, have followed the use of antipsychotic drugs, including HALDOL.

HALDOL may impair the mental and/or physical abilities required for the performance of hazardous tasks such as operating machinery or driving a motor vehicle. The ambulatory patient should be warned accordingly.

As with other antipsychotic agents, it should be noted that HALDOL may be capable of potentiating CNS depressants such as anesthetics, opiates, and alcohol."