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4301 MAPLESHADE LANE

PLANO, TX 75093

PATIENT RIGHTS: CARE IN SAFE SETTING

Tag No.: A0144

Based on record review and interview, the hospital failed to ensure a safe environment was provided for 4 of 21 patients (Patients #1, #2, #3, #4).

1. Patient #1, a patient involuntarily admitted for decompensated state of Psychosis and Aggression with expressed wish to kill others, had been placed on two-staff supervision after the patient attacked other patients, including Patient #2, and staff. The hospital did not have enough staff to provide that level of supervision.

2. Both Patients #3 and #4 had been admitted for Depression and/or Suicide. Hospital staff failed to prevent a verbal and physical altercation between the patients on 03/02/22 during which Patient #4 fell, suffered pain and/or bleeding on head and arm, and required emergency medical evaluation.

Findings included:


1. Record Review of Patient #1's Hospital High Risk Notification dated 03/02/22 at 0600 reflected diagnoses that included Psychosis and Aggression, Schizophrenia, Decompensated..., History of Ingesting Battery...Chronic Delusions of Being Raped...punched EMT [Emergency Medical Technician] x2 [twice] at the head, attacked 2 MHTs [Mental Health Technicians] with fist..."

Patient #1's History and Physical examination dated 03/02/22 at 0927 reflected the patient had been admitted for Psychosis, was "in restraints but got out of it and wanting to kill other people including officers...delusional, impulsive...volatile..."

Patient #1's Seclusion and Restraint Assessment dated 03/02/22 at 1308 reflected the patient had "struck another patient several times in the common area...separated by staff..."

During an interview on 03/08/22 at 1430, Hospital Personnel # 4 stated one patient, Patient #2, was sent out for emergency medical evaluation after being struck three times by Patient #1 and dragged by the leg on 03/02/22.


Patient # 1's Nursing Progress Notes dated 03/06/22 reflected the patient "...became violent and attacked a patient and staff..."

Patient #1's Physician Order #48980 dated 03/06/22 at 1705 reflected the patient to be placed on two-to-one staff (2:1) supervision. The order was "open-ended" without a stop date.

A phone interview was conducted with Hospital Physician #11 on 03/08/22 at 1245. Personnel #11 stated he wrote an order for Patient #1 to be on 2:1 staff observation after the patient "had assaulted other patients and staff."

Patient #1's Notes dated 03/07/22 at 1447 reflected Patient #1 was "placed in seclusion on 1:1 observation while waiting...for second staff for 2:1 order..."


During a phone interview on 03/08/22 at 1245, Hospital Personnel #7 stated the patient had an order to be supervised by two staff members but there was not enough staff for the patient to have two staff members.

Patient #1 was observed walking down the 1400 hall away from the nurses' station on 03/10/22 at or around 1355. One male staff member supervised the patient. Hospital Personnel #5 was asked whether the patient had been placed on 2:1 staff supervision and replied, "Yes, but we did not have the staff for it."

Record Review of Patient #1's Seclusion and Restraint Assessment dated 03/08/22 at 0957 reflected the patient was "anxious, angry, irritable." His behavior was "uncooperative ...still aggressive towards staff and patients."


Hospital Personnel #2 was asked on 03/10/22 at 1530 about the 2-staff supervision of Patient #1 on 03/07/22 and stated at that time that the hospital "did not have the staff to 2:1 supervision" and was changed the next shift.


Record review of staffing schedules dated 03/02/22 through 03/09/22 reflected only one mental health technician was assigned to Patient #1 per shift.




2. During an interview on 03/08/22 at 1430, Hospital Personnel #4 stated that on 03/02/22 at 1005, Patient #3 and Patient #4 had a verbal and physical altercation that caused Patient #4 to fall on the ground. Patient #4 complained of pain to the back of the head and was bleeding from the left ear lobe and right arm. Patient #4 was emergently sent out for medical evaluation on 03/02/22 at 1131.


Record review of Patient #3's Preadmission Evaluation Management and Medical Clearance document reflected an admission date and time to be 03/01/22 at 0249. The patient had made a suicide attempt.

Record review of Patient #4's Daily Nursing Note dated 03/02/22 at 1459 reflected the patient had been admitted for Depression and Suicide. Patient #4 "...was involved in a fight with another patient...fell down, got bruised left ear lobe and right arm...stated his head and back hurt...MD informed, gave order to send...[Patient #4] out for medical evaluation..."

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0160

Based on record review, interview and observation the hospital failed 1 of 1 Patient, (Patient #1) by using a drug or medication to restrict and manage or restrict Patient #1's behavior and restrict Patient #1's freedom o movement and is not a standard treatment or dosage for the patient's condtion.

Findings include:

During record review Patient #1 had a 45 day-order to be administered with injectable Haldol 5 mg, an antipsychotic medication, every 8 hours "as needed" for a non-DSM V psychiatric diagnosis.

During record review Patient #1 was had psychotropic medication administration that included:
a) a stat order for the maximum monthly dose of a long-acting injectable antipsychotic solution,
b) a daily oral antipsychotic medication,
c) a mood stabilizer, and an
d) an antidepressant.

During record review of Patient #1's electronic health record print out, provided to the surveyors on 03/10/22 at or around 1430 reflected Physician Order #49191 to administer "Haloperidol Lactate et Haldol 5mg/ml [milligram per milliliter] intramuscular injectable 5mg..every 8 hours as needed...Reason: Aggressive Behavior." The order's start date was 03/08/22 at 1251; its stop date was 04/22/22 at 1250.

During Record Review Patient #1's Physician Order #49294 dated 03/09/22 at 0834 reflected a "stat" dose (immediately to be administered) of "Paliperidone Palmitate et Invega Sustenna" 234mg Intramuscular Suspension, Extended Release. Patient #1 received the dose per intramuscular injection to the right deltoid muscle on 03/09/22 at 1222.

During record review b) Patient #1's Physician Order #49345 dated 03/09/22 at 0900 reflected the patient to receive Ziprasidone Geodon 40 mg every day in the morning. The patient was noted to have taken the medication, an atypical antipsychotic, on 03/10/22 at 0859.

c) Patient #1's Physician Order # 48611 dated 03/02/22 at 1320 reflected the patient to receive Divalproex Sodium Depakote ER 500 mg oral tablet, Extended Release, a mood stabilizer. 1000mg were to be administered at 2100 at bedtime for Mood and Depression diagnosis. The patient received the medication on 03/09/22 at 2048.


d) Patient #1's Physician Order # 49346 with a start date of 03/09/22 at 2100 and discontinued on 03/10/22 at 1232 reflected the patient to receive Trazodone Hydrocholoride "et Desyrel," an FDA approved atypical antidepressant, 50mg at bedtime daily. The patient received a dose of this medication on 03/09/22 at 2100. The Trazodone Hydrocholoride order was increased to 150mg per Physician Order #49454, dated 03/10/22 at 1230, and Physician Order#49455 dated 03/10/22 at 2100. The reason was noted to be Sleep Disturbance.

During observation of Patient #1, Patient #1 was in seclusion heavily sedated to prevent the patient from acting out aggressively in the milieu amongst other hospital patients. Patient #1 was slow to verbally respond, slurring his words and indicating that he was sick to the stomach today. Patient #1 stated that he had thrown up earlier, and leaking salvia from his mouth (slobbering). Patient #1 did not appear he could sit straight up, leaning against the wall seated on slumped over towards the right.

During observation Patient #1 was observed with very slow movements walking down the 1400 hall to the patient's room on 03/10/22 at 1355. Once in the patient room, Patient #1 very slowly walked to the bed, sat down, and responded to the surveyor.
During Interview with Hospital Staff #5, Staff #5 indicated that Patient #1 is unable to function in the milieu, therefore, he is being held in seclusion, medicated.

During interview hospital Personnel #2 stated during a personal interview on 03/10/22 at 1515 that he had been unaware of Patient #1's physician ordered Haldol 5 mg injection as needed for aggression and it was" an inappropriate order."

During interview with Hospital Staff #6, Staff #6 indicated that Patient #1 was being appropriately medicated due to the amount people that he has assaulted. Staff #6 indicated that Patient #1 has been observed by Staff #6, but there has been no interaction between the two of them. Staff #6 stated that the amount of medication given to Patient #1 was not excessive although Patient #1 was sick to the stomach vomiting.

During interview Personnel #4 stated during a personal interview on 03/10/22 at 1450 that Patient #1 had received Sustenna Invega and had required emergency administration of Ativan, Haldol, and Benadryl. Personnel #4 stated at that time that the team had just discussed an incident where the patient's "eyes had rolled back in his head."

The Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and the DSM-5-TR (to be published March 2022) did not reflect the diagnosis of Aggressive Behavior (https://www.psychiatry.org/psychiatrists/practice/dsm).


The National Institute of Health (2013) defined polypharmacy in Psychiatry as the administration of "two or more psychiatric medications ... to treat the same condition" and noted its demerits to include "increased adverse drug reactions and the severity of those reactions" (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3653237/)

The manufacturer of Invega Sustenna noted the maximum monthly dose of the medication was 234 mg warned that serious side effects of the medication included abnormal eye movements, sleepiness, and drowsiness (https://www.janssenschizophreniainjections.com/long-acting-injections/invega-sustenna?gclid=EAIaIQobChMIisrA1K-_9gIVYRpMCh2oagpuEAAYASAAEgLKiPD_BwE&gclsrc=aw.ds).
Policy

The hospital Policy Seclusion and Restraint dated 07/2021 reflected, "When restrictive behavior management techniques are necessary, the hospital chooses the least restrictive technique from among those that are approved for use before progressing to more restrictive behavior management techniques. Timeouts and procedures using restraining devices or aversive techniques are used only in a manner consistent with the patient's plan of care, policies and procedures, and state and federal laws ...The use of targeted observation (11, 2:1, or every 5 minutes) as well as mechanical restraints and seclusion as treatment interventions is prohibited except for patients who exhibit unsafe selfcare needs or intractable behavior that is severely self -injurious or injurious to others, who have not responded to all, least restrictive measures, interventions and who are unable to contract with staff for safety ...Orders for seclusion and/or restraint shall never be written as a standing order or on as needed basis (PRN). Seclusion is never used as a means of coercion, discipline, convenience or staff retaliation. Hospital leadership strives to eliminate the use of seclusion and restraint through staff training, thorough assessment, effective treatment planning, management of the environment, and ongoing performance improvement efforts. All staff, including the Physician or LIP that maybe ordering the use if Seclusion or Restraint (in accordance with state law) are educated on the use o Seclusion or Restraint based on hospital policy, State and Federal Guidelines, and maintain active CPI Certification. Seclusion and/or restraint may only be ordered by a psychiatrist and only for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others after less restrictive interventions are ineffective or ruled-out ...History of ...physical abuse that would place the patient at greater psychological risk if seclusion is used ...The seclusion or restraint will be terminated at the earliest possible time when the patient can demonstrate compliance with identified release criteria. If it is determined that the patient no longer needs the intervention, the RN can discontinue the seclusion or restraint without an order but will obtain an order within 30 minutes of discontinuing the intervention."

The hospital Policy Nursing Services Integrated Assessment dated 02/01/17, "It is the policy of the facility to conduct a comprehensive assessment of all relevant factors contributing to the patient's current condition and goals of recovery."

The hospital Policy on Pharmaceutical Services Medication Management dated 08/2021 reflected, "The policy of the Hospital is to ensure the following:
1. The physician/practitioner/psychiatrist assesses the patient and as part of the comprehensive treatment program and may order medications when appropriate for the treatment of the behavioral health disorder. This includes patients with psychotic disorders.
2. All medication orders shall be transmitted to the Pharmacy.
3. Any clarification or verification of orders shall be done between the pharmacist/nurse and the ordering physician.
4. b. Policy items 203 do not apply in urgent situations when the resulting delay would harm the patient including situations in which the patient experiences a sudden change in clinical status.
5. a. Appropriateness of the drug, dose, frequency, and route of administration
b. Therapeutic duplication
c. Real or potential allergies or sensitivities
d. Real or potential interactions between the prescription and other medications, food, and laboratory values.
6. When a medication is order is received in the Pharmacy and
clarification or verification is needed, the pharmacist is responsible.

The hospital Policy for Emergency Medications 'Medication Management' dated 06/2020 reflected, "The policy of Kindred Hospital is to ensure the following:
1. Emergency drugs and supplies, for use in medical emergencies only, shall be immediately available at each patient care unit or services area. Emergency medications contained in the crash carts will be provided in the most ready-to-administer form available and in age-specific doses ...will determine the contents of the carts and auxiliary emergency medication boxes, utilizing current specific criteria, recommended guidelines.
2. The emergency drug supply shall remain inside the cart, number sealed, always when not in use. The seals will be broken only when an emergency arises or when necessary for quality control checks. The cart's contents list shall reside on the outside of the cart and shall include the earliest drug expiration date within the cart.
3. When emergency medications or supplies are used, the hospital replaces them as soon as possible to maintain a full stock. The final seal used by pharmacy shall be a numbered seal with a distinctive color that is supplied by the pharmacy only."

The hospital Policy for Dispensing of Medications dated 06/2019 reflected, "The policy of Kindred Hospital is to ensure the following:
1. The hospital dispenses quantities of medications that are consistent
with patient's needs.
2. The hospital dispenses medications and maintains records in accordance with state and federal law and regulations, licensure, and professional standards of practice.
3. The hospital dispenses medications within time frames it defines to meet patient's needs.
4. Medications are dispensed in the most ready-to administer forms commercially available, and if feasible. N until doses that have been repackaged by the pharmacy or licensed re-packager.
5. No medication may leave the pharmacy without being checked by a pharmacist along with his/her initials as documented evidence.
6. Medication guides will be issued with certain prescribed drugs and biological products that meet the following criteria.
a. Certain information is necessary to prevent serious adverse effects
b. Patient decision-making should be informed by information about a known serious side effect with a product, or
c. Patient adherence to directions for the use of a product are essential to it effectiveness
d. Medication guides will be provided per REMS criteria."

The hospital Policy on Emergency Psychotropic Medication dated 03/22 reflected, "The policy of The Hospital is to ensure the following:
" The Hospital provides guidelines for the appropriate use of
psychotropic medications and ensures that such medications are
only used for the purpose of treating acute sudden onset
psychiatric symptoms that cannot be managed through oral
medication or other crisis intervention protocols. Emergency
psychotropic medications are never used to limit the freedom
of movement of patients.
" Emergency medications and supplies, for use in behavioral health
emergencies only, shall be immediately available at each patient
care unit or service area and administered as per the following:
Stipulations for use of emergency medications: The use of
psychotropic medication to limit or restrict freedom of movement
is not permitted.
" Psychotropic emergent medication maybe administered to address
sudden outbursts and escalation of symptoms.
" An order for emergency psychotropic medication by the physician
is required and will be administered as ordered.
" Orders for emergent psychotropic medications will not be given as
PRN medication.
" If administration is required beyond the single episode an additional
order must be obtained from a physician.
" Such medications can only be administered in response to
symptoms of increased agitation
uncontrolled by the patient's routine medications.
" Emergency psychotropic medications, given only as defined above,
shall be treated as a special treatment procedure
" A list of all locations where emergency psychotropic medications
are stored will be maintained by pharmacy services.During obervation Patient #1 was observed to