Statement of Deficiencies

Statement of Deficiencies	(X1) Provider/Supplier/CLIA Identification Number 670093	(X3) Date Survey Completed 05/11/2023
Name of Provider or Supplier Aspire Hospital	Street Address, City, State 2006 South Loop 336 West, Suite 500, Conroe, TX
For information on the provider's plan to correct this deficiency, please contact the provider or the state survey agency.

(X4) ID Prefix Tag

Summary Statement of Deficiencies

(Each deficiency should be preceded by full regulatory or LSC identifying information)

A0160

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:
Based on review and interview the facility failed to: A. ensure that chemical restraints administered were identified as a chemical restraint/ emergency behavioral medication (EBM) B. ensure a process was in place for continuous monitoring after administering a chemical restraint/emergency behavioral medication for side effects, respiratory or cardiac distress, and assessment of medication effectiveness and safety after administration in 3 of 3(Patients #1,4, and 5) patient charts reviewed. C. follow their own policy and procedures to ensure the restraint packet was filled out appropriately and completely, a face-to-face was conducted by a trained individual, and patient/ staff debriefing was completed and appropriate in 3 of 3(Patient #1,4, and 5) charts reviewed. D. ensure chemical restraints were added to the restraint log and monitored through Risk and Quality in 3 of 3(Patient #1, 4, and 5) charts reviewed. The deficient practices were identified under the following Condition of Participation, CFR 482.13 Patient Rights, and were determined to pose an Immediate Jeopardy (IJ) to patient health and safety and placed all patients in the facility at risk for the likelihood of harm, serious injury, and possible death. A review of patient #1's chart revealed he was admitted to the facility on 4/8/23 for depression without psychotic features. Patient #1 was placed on suicidal precautions. A review of the 12-hour nursing assessment revealed Staff #1 documented that patient #1 was "agitated and angry." Patient #1 wanted to smoke, and the facility was a non-smoking facility. There was no documentation that the patient was offered any other alternatives for smoking. Patient #1 started to bang on the nurse's station window and made threats toward staff. The nurse documented, "Pt encouraged to follow the treatment plan and medication regimen, pt. redirected many times to stay calm and not to make threats and recited the policy on smoking in the hospital." The psychiatrist was notified by phone and a verbal order was given for Haldol 10 mg IM "take now" and Ativan 4 mg IM "take now". A review of the Medication Administration Record (MAR) revealed Staff #24 Licensed Vocational Nurse (LVN) administered the restraint medication on 4/10/23 at 9:45 AM and 9:50 AM. There was no found evidence that the patient was removed from the situation, placed on a 1:1, placed in seclusion, or had therapy services intervene. There was no other documented evidence that any other restraint process was used before administering a chemical restraint. A review of Staff #1's nursing note documentation revealed on 4/10/23 at 10:12 AM, "Pt became calm and willing to receive emergent medication by staff at 0945 (9:45 AM)." There was no evidence that the patient was offered po meds. There was no documented justification of why patient #1 received an emergent IM chemical restraint if he was calm and willing to take medications. A review of the q15 min observation sheet revealed the mental health technician (MHT) had pre-charted the q15 min observations. The MHT had charted from 8:00 AM thru 9:45 AM that the patient was in his bedroom and hallway with no abnormal verbal behavior. The MHT then wrote over the top of the previous documentation from 8:15 AM thru 9:30 AM that the patient was repetitive, making noises, complaining, and constant requests for attention. A review of patient #1's chart revealed a restraint/seclusion packet dated 4/10/23 at 9:45 AM. The packet included the following forms: A. Physician order for restraint. The packet was filled out by staff #19 RN. Staff #19 signed the order stating she took the verbal order for the restraint medication on 4/10/23 at 9:25 AM. Staff #19 failed to fill out the section for clinical justification for the use of restraint. The order was never signed or authenticated by the physician. B. face-to-face. A review of the face-to-face form dated 4/10/23 at 10:45 AM revealed no vital signs were documented. The vital signs were left blank with no reason documented. Staff #39 RN assessed the patient for a face-to-face. It was confirmed by Staff #1 on 5/9/23 that Staff #39 did not have face-to-face training. C. Staff debriefing. A review of the staff debriefing form revealed the form was dated 4/10/23 at 9:35 AM 10 minutes before the patient was given a chemical restraint. There was no information on what staff was in attendance. Staff #39 left the questions on the form blank on "triggers or early signs of agitation and what could the staff do to minimize those triggers to avoid a chemical restraint." The only de-escalation technique documented was "communication." A review of the restraint and seclusion policy and procedure stated, "A post-restraint or post-seclusion staff debriefing occurs as soon as possible, but no longer than 24 hours. The content of the staff debriefing includes the following: Assessment of the effectiveness of less restrictive alternatives or methods to prevent further episodes, Identification of patient triggers, Effectiveness of de-escalation techniques, approaches and/or staff communication, Compliance with restraint and seclusion policies, Evaluation and prevention of staff or patient injuries, The results of the debriefing will be documented and reviewed for performance improvement initiatives." Patient debriefing. The patient did not participate in the patient debriefing due to "sleeping." There was no found documentation of any debriefing performed with patient #1 after he awakened. A review of the restraint and seclusion policy and procedure stated, " 4.4.4 Post restraint or Post-seclusion Patient and Staff Debriefing. A post-restraint or post-seclusion patient debriefing will occur as soon as possible, but no longer than 24 hours, after the restraint or seclusion episode. The content of the patient debriefing after each episode of restraint or seclusion includes the following: Identification of what led to the use of restraint or seclusion and what could have been done differently. Ascertainment that the patient's well-being, psychological comfort, and right to privacy were maintained Counseling of the patient for any physical or psychological trauma that may have resulted from the use of restraint or seclusion. Modification of the patient's plan of care, if indicated. The results of patient debriefing will be documented in the patient's medical record." A review of patient #1's nurse note dated 4/10/23 at 2:00 PM stated, "up from bed, screaming, yelling, hitting the windows. Geodon/Ativan 20/2 given IM at left buttocks. Patient sleeping." A review of the physician orders revealed patient #1 was ordered: "Geodon 20mg INJ NOW, and Ativan 2 mg IM NOW." There was no reason documented on the order for the chemical restraint/EBM. A review of the MAR revealed the nurse administered the medications IM on 4/10/23 at 2:00 PM. A review of the restraint packet revealed the medications administered were not administered IM but by mouth. The physician failed to sign the seclusion order form. There was no debriefing with the patient documented or with any staff. There was no documentation on the effects of the medication, the patient's disposition, or vital signs until 4:30 PM. A review of the nurse's notes dated 4/10/23 at 4:30 PM stated, "Up again, Dr ____ and /____(physician) notified, pt on 1:1. Fall precautions." A review of patient #1's chart revealed there was no found order for a 1:1 on 4/10/23. A review of the observation sheet revealed the patient was not on a 1:1 and was documented as in the hallway and dining room with no behavioral issues. The MHT documented no abnormal verbal behavior from 4:00 PM until 5:00 PM. A review of patient #1's vital sign sheet in the chart revealed he had no vital signs taken until 5:00 PM on 4/10/23, 7 hours after his first injection and 3 hours after his second. A review of the restraint and seclusion policy and procedure revealed there was no process for patient nursing assessment or reassessment after the administration of a chemical restraint/EBM. There was no process for how frequently the nurse was to reassess the patient and for how long. There was no found education to staff on how to assess and reassess a patient after a chemical restraint was administered. According to the manufacturer insert Haldol (Haloperidol) is an antipsychotic medicine that is used to treat schizophrenia and psychosis. It can also be used for psychiatric emergency behavioral situations. Any patient receiving these medications should be monitored by a trained medical professional due to the side effects of Anemia, Headache, Increased or Decreased respiratory rate, Orthostatic hypotension, Prolonged QT interval, and Visual disturbances. Geodon (Ziprasidone) belongs to a class of drugs called atypical antipsychotics used to treat schizophrenia. It is also known as a second-generation antipsychotic (SGA) or atypical antipsychotic. Ziprasidone rebalances dopamine and serotonin to improve thinking, mood, and behavior. All antipsychotics have been associated with the risk of sudden cardiac death due to an arrhythmia (irregular heartbeat). To minimize this risk, antipsychotic medications should be used in the smallest effective dose when the benefits outweigh the risks. All antipsychotics can cause sedation, dizziness, or orthostatic hypotension (a drop in blood pressure when standing up from sitting or lying down). These side effects may lead to falls which could cause bone fractures or other injuries. This risk is higher for people with conditions or other medications that could worsen these effects. Summary Of FDA Black Box Warnings Increased Mortality in elderly patients with dementia-related psychosis. Both first-generation (typical) and second-generation (atypical) antipsychotics are associated with an increased risk of mortality in elderly patients when used for dementia-related psychosis. Although there were multiple causes of death in studies, most deaths appeared to be due to cardiovascular causes (e.g., sudden cardiac death) or infection (e.g., pneumonia). Antipsychotics are not indicated for the treatment of dementia-related psychosis https://www.nami.org/About-Mental-Illness/Treatments/Mental-Health-Medications/Types-of-Medication/Ziprasidone-(Geodon). An interview was conducted with Staff #1, Staff #16, Staff #11, and Staff #22 in the afternoon of 5/9/23. Staff #1 confirmed there was no written nursing process for assessment and reassessment of a patient that had received a chemical restraint. Staff #11 stated that he assessed patients that received a chemical restraint very regularly. Staff #11 stated that he tried to check on them every 15 minutes but did not know for how long. Staff #11 stated, "I would be very interested in knowing what the rule is on reassessment." Staff #22 stated as an LVN (licensed vocational nurse) she had been administering chemical restraints/EBM but was unaware of any process in how often to assess the patient. Staff #11 and staff #12 were unaware that there was no antidote to psychotropic medications and were not aware of the black box warnings on Haldol or Geodon. Staff #16 stated that he was not aware that there was no direction from Medical Staff on how to assess the patient after a chemical restraint was administered. Staff #16 stated that he would call an ad-hoc meeting with medical staff to discuss and resolve the issue. The nursing staff interviewed was unable to voice their complete understanding of a chemical restraint/ emergency behavioral medication administration and how to assess for any emergencies or adverse effects. An interview was conducted on the morning of 5/9/23 with Staff # 1 and Staff #2. Staff #1 confirmed that there was no restraint log. Staff #1 was unable to confirm who had received a restraint or what type. Staff #2 was asked how Quality assessed restraints and restraints use if the facility had no log. Staff #2 stated that when a patient is restrained the nurse was to fill out a restraint packet and Staff #2 would pick those up every day. Staff #2 stated that she would do a quality assessment on the restraints to see if there were any problems. Staff #2 was shown the pharmacy log that revealed multiple patients receiving IM psychotropic medications as "now" orders for behavioral emergencies that had no restraint packets. Staff #2 stated that she had just started in this position, and she was told that the previous QAPI director was monitoring the restraints but that she had not been able to compile the information and was not monitoring the restraint process in QAPI at this time. The following patient charts revealed there were incomplete restraint and seclusion forms, failure to assess the patient after the administration of a chemical restraint/ EBM, and failure to log the restraint and follow through with QAPI to ensure the safe administration of a chemical restraint/EBM. Patient #4 A review of patient #4's chart revealed he was administered a chemical restraint/EBM on 2/15/23 at 9:00 AM. The nurse documented he was "Agitated and aggressive towards staff ... Yelling and screaming ...believes everyone is a cop." The staff attempted to redirect the patient but did not document what that consisted of. The physician was called and a telephone order for Ativan 1 mg IM, Haldol 10mg IM, and Benadryl 100mg IM was ordered and administered. There was no further information on the effectiveness of the medication. There were no documented vital signs until 5:45 PM, 8 ½ hours after the medication was administered. A review of the restraint packet on the face-to-face dated 2/15/23 at 9:30 AM stated, "Patient was agitated, aggressive, uncontrollable, and refused direction ... voluntarily took emergency medication and tolerated well." Patient #1 was documented as "willing" to take medication however, there was no documentation on why medications were not offered by mouth. The nurse documented she was unable to assess the patient due to sedation. The nurse checked the box that stated, "The patient was assessed, verbalized understanding of the release criteria at this time, and restraint or seclusion should be discontinued." The nurse stated no vital signs due to sedation, but the patient was able to verbalize understanding of the restraint and release criteria. There were no documented release criteria for a chemical restraint/ EBM. There was no documented patient debriefing or names of staff involved with the staff debriefing. Patient #5 Review of patient #5's nursing note, staff #21 RN documented that on 2/9/23 at 11:50 AM, "Patient started screaming and yelling expletive at another patient. Patient was very agitated. 12:00 PM Haldol 10mg IM, Ativan 4mg IM, and Benadryl 100mg IM given with the patient's consent and patient tolerated well." 12:30 PM Patient is ambulating in the unit, calm, and quiet, interacting with staff and patients. Denies any side effects. Went to group." There was no explanation documented why the patient was not offered medications in pill form if he was willing to take medications. A review of the face-to-face dated 2/9/23 at 12:30 PM stated the patient was sedated and refused vital signs. However, the nurse documented on the face to face that patient #5 was alert, and oriented to person and place. There was no time or date on when the patient debriefing took place. Upon the patient signature line, it stated, "refused". There was no time or names for any staff debriefing. A review of the seclusion/restraint progress note revealed the note had no date or time. 40989 An interview was conducted on 5/09/2023 at 9:00 AM with Staff #20 and #21. Staff #20 was asked how long the patient was monitored after a chemical restraint/EBM (emergency behavioral medication) was administered. Staff #20 stated, "After they get a shot, we try and keep them in their room for the first 30 minutes. You know, just so they don't fall. Then we will go back and check on them in an hour or so. The techs will watch them and tell us if there is a problem." Staff #20 was asked if an assessment and vital signs (blood pressure, temperature, heart rate, respiratory rate, and oxygen level) were taken and documented. Staff #20 stated, "Not all the time because the patient will refuse, or they may be sleeping." Staff #20 was asked if he documented a respiratory rate if the patient was sleeping or if the patient refused the vital sign assessment. Staff #20 stated, "If I tell you the patient refused, then that should be good enough. If the patient is talking and refuses, then you know the patient is alive. There is no reason for me to document a respiratory rate." Staff #21 was asked if a restraint packet was always completed when a patient received an IM (intramuscular) injection of an EBM. Staff #21 replied, "No, not all the time, but I do most of the time. If a patient takes the medications willingly, sometimes we don't do a restraint packet. Like Patient #26 would come and ask for a shot of Haldol and Ativan because he was very anxious and agitated. We would call the doctor and get an order. Then, most of the time he would just go and sleep. Since he asked for the shot, we didn't do a restraint packet because he took it willingly."