HospitalInspections.org

Based on record review and interview, the Governing Body failed to

A. ensure that chemical restraints were performed safely, patients were assessed and reassessed, and a face to face was performed per the facility's policy. Ensure that emergency behavioral medications that were given Intramuscular (IM) to 4 (Patient's #2, #16, #18 and #19) of 6 patients for behavioral emergencies were identified and monitored as a chemical restraint.

B. assess and monitor patients that received anesthesia medications, per drug manufacturer guidance and the facility's policy and procedure, for Moderate to Deep sedation in 3(#20, 23 and 24) of 3 patient charts reviewed.

Cross Refer to Tag A0144


It was determined that these deficient practices posed an Immediate Jeopardy to patient health and safety and placed all patients at risk for the likelihood of harm, serious injury, impairment and /or subsequent death.


C. ensure that the Quality Department provided ongoing tracking, trending, and analysis data of incidents submitted in the Incident Reporting System to the Patient Safety Triage Team, Quality Improvement Committee, Medical Executive Committee, and Board of Trustees. This information would be necessary for these committees to ensure that appropriate corrective actions had been taken and were sustained in the improvement of patient safety.

Cross Refer to Tag A0286


D. provide adequate resources in the form of trained, experienced, or knowledgeable staff to effectively measure and assess potential risks to patients reported through the incident reporting system. The Incident Reporting System was the primary reporting system for the Patient Safety Program. Information on tracking, trending, and evaluation of incident reports by categories in order to evaluate the effectiveness of the incident reporting system was not available.

Cross Refer to Tag A0315

Based on document review and interview the facility failed to

A. ensure that chemical restraints were performed safely, patients were assessed and reassessed, and a face to face was performed per the facility's policy. Ensure that emergency behavioral medications that were given Intramuscular (IM) to 4 (Patient's #2, #16, #18 and #19) of 6 patients for behavioral emergencies were identified and monitored as a chemical restraint.

B. assess and monitor patients that received anesthesia medications per drug manufacturer guidance and the facility's policy and procedure for Moderate to Deep sedation in 3(#20, 23 and 24) of 3 patient charts reviewed.

Cross Refer to Tag A0144

It was determined that these deficient practices posed an Immediate Jeopardy to patient health and safety and placed all patients at risk for the likelihood of harm, serious injury, impairment and /or subsequent death.

C. appropriately identify when a drug or medication was used as a restraint and develop policies and procedures for the safe use, documentation, monitoring of patient, and quality monitoring of drugs or medications used as restraints.

Cross Refer to Tag A0160

Based on document review and interview the facility failed to

A. ensure that chemical restraints were performed safely, patients were assessed and reassessed, and a face to face was performed per the facility's policy. Ensure that emergency behavioral medications that were given Intramuscular (IM) to 4 (Patient's #2, #16, #18 and #19) of 6 patients for behavioral emergencies were identified and monitored as a chemical restraint.

B. assess and monitor patients that received anesthesia medications per drug manufacturer guidance and the facility's policy and procedure for Moderate to Deep sedation in 3(#20, 23 and 24) of 3 patient charts reviewed.

The deficient practices were identified under the following Conditions of Participation and were determined to pose Immediate Jeopardy to patient health and safety and placed all patients at risk for the likelihood of harm, serious injury, and possibly subsequent death.


Findings for A Include


PATIENT #2

A review of Patient #2's medical record was conducted with Staff #10, Staff #11, and Staff #12 on 02/10/2022 after 10:00 AM and revealed the following:

Patient #2 was a 66-year-old female transported to the Emergency Department on 9/10/2019 by the Police Department on an Emergency Detention Order (EDO). Patient #2 was delusional, had rambling speech, and exhibited aggressive behavior upon admission. The past medical history was noted as Asthma, Bipolar 1, Breast Cancer, Hypertension, and Myocardial Infarction (Heart Attack). Patient #2 was admitted to the Behavioral Health Unit on 9/10/2019.

A review of the document titled, "Progress Notes, Nursing Narrative" dated 9/10/2019 at 20:20 (8:20 PM) by Staff #20 was as follows:

" ...Pt irritable and delusional. Pt delusional about different peers and staff on unit being voodoo queens and kings. Pt especially angry at Staff member, states staff member was once a man but grew her hair out in an effort to put voodoo curse on her. Pt calls staff member a Vietcong voodoo priest. Pt hypervigilant about her safety and need to protect herself. Pt delusional about being in law enforcement and wants me to call her coworker "Tiffany for back up". Pt given emergency behavioral medications [medications used in an emergency when a patient is a threat to themselves or others i.e. Haldol (antipsychotic drug), Benadryl (a drug used for the sedative effects), and Ativan (a benzodiazepine drug used for the treatment of anxiety and has a sedative effect] at this time to prevent worsening of symptoms. Will continue to monitor ..."


A review of the document titled; "Now Order for Involuntary Emergency Administration of Psychoactive Medication" was as follows:

" ...Date: 9/10/2019 Time: 19:45 (7:45 PM)
Haldol 5 mg IM X 1
Benadryl 25mg IM X 1

Pt making threats to harm staff and peers on unit. Delusional about staff/peers wanting to put spell on her.

TO (telephone order) Staff #25/TORB Staff #20 Date: 9/10/2019 19:45 (7:45 PM) ..."

A review the electronic document titled "Orders" by Staff #26 was as follows: " ...Order Comment: emergency dose medication for agitation ..."

A review of the Medication Administration Record revealed Benadryl 25mg and Haldol (antipsychotic drug) 5 mg was given Intramuscular in the left Ventrogluteal (hip) by Staff #20.

Staff #10 confirmed no documentation was found within the medical record if Patient #2 required a hold for the IM injection.


According to accessdata.fda.gov Haldol is an antipsychotic drug that can cause a serious and sometimes fatal side effect known as NMS and should be monitored closely.
" ...Neuroleptic Malignant Syndrome (NMS)
A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status (including catatonic signs) and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmias) ..."


According to accessdata.fda.gov Benadryl is classified as an antihistamine that can have severe side effects such as Hypotension, headache, tachycardia, palpitations, sedation, can cause tightness in the chest and wheezing.


Patient #2 had a history of a MI (Myocardial Infarction-heart attack) and Hypertension (High Blood Pressure) and should have been monitored closely for serious adverse reactions.



A review of the policy titled, "Use of NOW Psychoactive Medications", Policy Number BH-6 with a review date of 5/12/2020 was as follows:

" ...Documentation and Monitoring

1. If the patient DOES NOT consent to emergency NOW medication administration, and a physical hold is required, the medication must be documented on the NOW Medication Log. A physical hold is considered a restraint and must be documented as such according to the Restraint and Seclusion policy, inclusive of a Face-to-Face examination within 1 hour.

2. All patients receiving emergency NOW medication will be reassessed for adverse reaction, effectiveness of medication, and vital signs including Blood Pressure, Heart Rate, SPO2 within 30 minutes of an IV/IM injection and 60 minutes of a PO medication ..."


The "Use of NOW Psychoactive Medications" policy did not give a clear definition to staff on what constitutes a chemical restraint. The policy failed to direct the staff on how long to monitor the patient receiving an intramuscular injection of an emergency medication.



Further review of the medical record revealed vital signs were taken at 5:15 PM on 9/10/2019. This was 2 hours and 55 minutes before the emergency medication was given. Vital signs were not taken again until 9/11/2019 at 3:04 PM. 18 hours and 44 minutes after the emergency medication was administered. Staff #10 confirmed there was no documentation within the medical record that nursing staff attempted to take vital signs and/or Patient #2 refused to have vital signs taken.


A review of the policy titled "Restraint and Seclusion - Texas Behavioral Health Units", Policy number: (blank), Origination Date: 3/10/2021 was as follows:

" ...Policy
It is the policy of Steward Health Care that all patients have the right to be free from restraints or seclusion of any form, imposed as a means of coercion, discipline, convenience or retaliation by staff. As such, efforts are ongoing to afford behavioral health patients care in a restraint-free and seclusion-free environment.

Restraint or seclusion is LIMITED TO EMERGENCIES when there is imminent risk of, and present ability to effect, physical harm to the patient or others and only when less restrictive measures have failed, or after a determination that such alternatives would be inappropriate or ineffective under the circumstances.

Scope

This policy applies to all inpatient psychiatric units. For Non-Behavioral Health Units refer to hospital policy for Restraint and Seclusion for Non-Behavioral Health Units.

Definitions

Behavioral Emergency: A situation involving an individual who is behaving in a violent or self-destructive manner and in which preventive, de-escalative, or verbal techniques have been determined to be ineffective and is immediately necessary to restrain or seclude the individual to prevent:
1. imminent probable death or subsequent bodily harm to the individual because the individual is attempting to commit suicide or inflict serious bodily harm; or
2. imminent physical harm to others because of acts the individual commits.

Chemical Restraint: The use of any chemical, including pharmaceuticals, through topical application, oral administration, injection, or other means, for the purpose of restraining an individual and which is not a standard treatment for the individual's medical or psychiatric condition. Chemical restraints are prohibited.

Emergency Medication: A psychoactive medication that is used to treat the signs and symptoms of mental illness in a psychiatric emergency, when other interventions are ineffective or inappropriate.

II.ORDERING AND APPLICATION OF RESTRAINT
...
E. Emergency Medication Orders
...
5. All patients receiving emergency medications will be assessed for adverse reactions and effectiveness of the medication. The assessment of the patient status will include the following elements:
A. Vital signs within 30 minutes of an intramuscular (IM)/intravenous (IV) injection and 60 minutes of an oral medication.

B. The patient responses to the medication in the behavioral terms within 30 minutes of IM/IV injection and 60 minutes of an oral medication.

C. Any de-escalation techniques performed prior to medication administered.

D. Any additional monitoring as outlined in the manufacturer's guidelines for the specific medication..."

Without the staff properly assessing and monitoring the patient for signs and symptoms of side effects after an IM injection of emergency behavioral medications, the patient was in danger of experiencing serious adverse effects, i.e. irregular heart rhythms or pulse rate, low blood pressure, wheezing that could lead to breathing difficulties, and NMS. Serious adverse reactions to these medications increases the probability of long term medical conditions.


An interview was conducted with Staff #11 and Staff #12 on 2/10/2022 after 10:00 AM. Staff #11 was asked if Patient #2 was assessed and monitored as a chemical restraint after receiving the Emergency behavior medications. Staff #11 stated, "We do not administer chemical restraints here at this facility. If we have an order from the provider for an emergency IM injection for a behavior emergency and the patient is willing to take the injection, then it is not a restraint. It is part of the patient's therapeutic regimen according to their diagnosis. If the patient is not willing and we have to hold the patient briefly to give them the injection, then we will document the brief hold in the medical record.

Staff #10, #11, and #12 confirmed there was no monitoring of Patient #2 after the emergency behavioral medications were given. No 1-hour face to face was completed on Patient #2 after the injection was administered. The "Use of NOW Psychoactive Medication" Policy was not followed.

On 2/10/2022 at 10:00 AM Staff #2 confirmed 4 (Patient's #2, #16, #18 and #19) of 6 patients receiving emergency "NOW" medications were not placed in a hold for the IM injection so therefore, no restraint documentation or monitoring was required.


PATIENT #16

Patient #16 was a 29-year-old female brought to the ED by the police department on 12/26/2021 on an Emergency Detention Order for being in a psychotic/manic/schizophrenic paranoid state. The patient was admitted to the Behavioral Health Unit on 12/26/2021 at 11:35 AM.

A review of the physician's orders dated 12/31/2021 at 10:50 AM by Staff #17 was as follows:

1. Diphenhydramine (Benadryl) 50 mg IM Once
2. Haloperidol Injection (Inj.) (Haldol Inj.) 5 mg IM Once
3. Lorazepam Inj. (Ativan Inj.) 2 mg IM Once

Emergency Medications were administered on 12/31/2021 at 11:00 AM by Staff #21. A review of Staff #21's nursing note dated 12/31/2021 at 11:00 AM was as follows: " ...patient did accept IM Haldol 5 mg, Ativan 2 mg, and Benadryl 50mg in her right deltoid patient accepted it without incident but she did continue to threaten staff."

Staff #21 documented the following:

" ...12/31/2019 11:50 AM patient is asleep, respirations are even and unlabored, x-ray here, portable x-ray of left ankle was performed without incident.

12/31/2021 12:51 PM patients sisters were here to visit, she was able to get up and spend a short time with them.

12/31/2021 14:10 (2:10 PM) patient is asleep, unable to awaken for vital signs. ..."

An interview was conducted with Staff #2 on 2/10/2022 after 10:00 AM. Staff #2 confirmed no vital signs were taken after the Emergency Medications were given on 12/31/2021 at 11:00 AM until 1/1/2022 at 3:27 PM. This was 29 hours and 37 minutes after the emergency medications were administered. Staff #2 also confirmed there was no documentation stating Patient #16 refused to have vital signs taken at any time and no restraint documentation or 1 hour face to face was completed.
Staff #2 stated a focused assessment was documented on 12/31/2021 at 11:50 AM. Staff #2 was asked to clarify what a focused assessment included. Staff #2 replied, "Well, that the nurse laid eyes on the patient and they were in no distress." During the review of the focused assessment documentations, Staff #2 confirmed no vital signs (Blood Pressure, Pulse, Respirations, or Oxygen level) were taken during the focused assessment.


PATIENT #18

Patient #18 was a 45-year-old male brought to the ED on 1/07/2022 07:24 by EMS on an Emergency Detention Order due to suicidal and homicidal ideation and suspected overdose on methamphetamine and cocaine. He was admitted to the Behavioral Health Unit on 1/07/2022 at 3:30 PM. Vital signs were taken on initial assessment at 4:14 PM. Vital signs were recorded as Blood pressure 162/98, pulse 130, respirations 22, and oxygen saturations was 100% on room air. Staff #2 confirmed there was no documentation in the medical record that the abnormal vital signs were reported to the MD.

A review of the nursing note by Staff #21 was as follows:

" ...1/07/2022 at 17:53 (5:53 PM) by Staff #21, patient is currently in the dayroom hollering, screaming, twirling around with his hands and arms in the air, agitated, paranoid, shaking, unable to redirect patient, called Staff #17 for medications, order received ..."

A review of the 1:1 observation document dated 1/07/2022 by the Mental Health Tech between 4:45 PM and 6:00 PM documented the patient was restless and disorganized. There was no documentation by the MHT that the patient was screaming or yelling.

A review of the medication orders from Staff #17 was as follows:
" ...1/07/2022 6:00 PM Haldol Inj. 5 mg IM Once
1/07/2022 6:00 PM Benadryl Inj. 50 mg IM Once
1/07/2022 6:00 PM Ativan 2 mg Inj. IM Once ..."

A review of the Nurses notes by Staff #21 was as follows:

"01/07/2022 at 6:11 PM, "patient medicated with Ativan 2 mg, Haldol 5 mg, and Benadryl 50 mg IM in his left gluteal without incident, patient is extremely diaphoretic."

A review of the Nurses notes by Staff #22 was as follows:

"1/07/2022 at 8:43 PM Pt asleep at this time in his bed, snoring, resp even unlabored, no s/s (signs and symptoms) of distress, routine safety checks"

Staff #2 confirmed there was no restraint documentation or 1 hour face to face completed after the emergency medications were given.


PATIENT #19

Patient #19 was a 25-year-old female admitted to the facility on 1/27/2022 at 4:57 PM for suicidal ideation and auditory hallucinations.

A review of the nurses' notes dated 1/29/2022 by Staff #25 was as follows:

"1/29/2022 01:41 AM-Patient very combative and hollering ambulating down covid hall unable to redirect notified Staff #16 new orders noted.

1/29/2022 02:07 AM - Patient refuse po medication very aggressive behavior swinging at staff combative, screaming louding (sic) saying she is getting out of here and very religious ranting throwing herself on floor and hitting herself in chest. Attacking staff as if to hit and very intrusive them and bracing up to them saying you can not tell me what to do continue to redirect unsuccessful. Call Staff #16 new orders noted.

1/29/2022 03:07 AM- Medication one time dose given to patient tolerated well still threaten and hollering a few minutes then took bath and went to sleep"

A review of the document titled; "Now Order for Involuntary Emergency Administration of Psychoactive Medication" was as follows:

" ...Date: 1/29/2022 Time: 02:45 AM
Haldol 5 mg IM
Ativan 1mg IM
Benadryl 50mg IM

TO (telephone order) Staff #16/Staff #25 Date: 1/29/2022 Time 02:45 AM ..."


Further review of the medical record revealed vital signs were not taken after emergency medications were given until 1/29/2022 at 1:27 PM. This was 10 hours and 34 minutes after the emergency medications were administered for a behavior emergency.

Staff #2 confirmed no restraint monitoring or 1 hour face to face was completed.


An interview was conducted with Staff #2 on 2/10/2022 after 1:00 PM. Staff #2 was asked if the facility used chemical restraints. Staff #2 replied, "We do not do chemical restraints at this facility. Staff #2 was asked if the facility used Emergency Behavioral Medications. Staff #2 confirmed that Emergency Medications were used for emergency behaviors when a patient was a threat to themselves or others and a part of the patient's therapeutic regimen related to their diagnosis. Staff #2 also stated they were not considered a restraint so therefore they were not documented as a restraint. We document the hold as a restraint if we have to hold/restrain the patient to administer the medication."



A review of the policy titled, "Use of NOW Psychoactive Medications", Policy Number BH-6 with a review date of 5/12/2020 was as follows:

" ...Procedure:

Use less intrusive treatment

If less intrusive treatment is not effective, administer PRN/NOW psychoactive medications as indicated.

Consent

The patient must consent to the administration of PRN psychoactive medications.

Exception: NOW Orders, see below

NOW Orders

The physician may issue a NOW order to administer psychoactive medication without the patient's consent in an emergency.

PRN Order

The physician may consider a "NOW" dose of one with IM (intramuscular) injections of Ativan and Haldol. S/he should consider using the same IM neuroleptic as the scheduled one where possible.

Not all patients follow this progression and may require significant interventions earlier. Staff and physicians must use their clinical judgment based on individual patient's needs.

.
Documentation and Monitoring

1. If the patient DOES NOT consent to emergency NOW medication administration, and a physical hold is required, the medication must be documented on the NOW Medication Log. A physical hold is considered a restraint and must be documented as such according to the Restraint and Seclusion policy, inclusive of a Face-to-Face examination within 1 hour.
2. All patients receiving emergency NOW medication will be reassessed for adverse reaction, effectiveness of medication, and vital signs including Blood Pressure, Heart Rate, SPO2 within 30 minutes of an IV/IM injection and 60 minutes of a PO medication ..."

The policy reviewed above, "Use of NOW Psychoactive Medications", allowed for the use of medication given during a behavioral emergency to be ordered PRN. The policy did not recognize that a medication given during a behavioral emergency could not be ordered PRN (as needed to be given should a patient have a behavioral emergency). An order written for an IM injection of Haldol and Ativan on a PRN (as needed) schedule allows the Nursing staff to make a clinical decision when to administer an emergency behavior medication without first consulting with the provider.



Staff #2 confirmed the findings.




32143

B.

1. Review of Patient #20 revealed she was a 37 y/o female that was brought to the emergency department (ED) on 1-9-22. The ED nurses triage note stated, "Patient here under EDO (Emergency Detention Order) from Orange Co. for trying to burn family's house down and assaulting officer, given Ketamine 500mg IM by EMS."

According to accessdata.fda.gov "Ketamine is a medication primarily used for induction and maintenance of anesthesia. It induces dissociative anesthesia, a trance-like state providing pain relief, sedation, and amnesia ...It distorts perceptions of sight and sound and makes the user feel disconnected and not in control. It is an injectable, short-acting anesthetic for use in humans and animals. It is referred to as a "dissociative anesthetic" because it makes patients feel detached from their pain and environment."

The use of Ketamine can be given in doses that can put a patient in different levels of sedation. Review of the facility's policy and procedure "Management of Moderate and/or Deep Sedation by Non-Anesthesia Personnel" stated,
"Minimal sedation (anxiolysis): A drug-induced state during which patients respond normally to verbal commands. Although cognitive function and coordination may be impaired, ventilatory and cardiovascular functions are unaffected.

Moderate Sedation/Analgesia ("conscious sedation"): A drug-induced depression of consciousness during which patients respond purposefully to verbal commands, either alone or accompanied by light tactile stimulation. No interventions are required to maintain a patient airway, and spontaneous ventilation is adequate. Cardiovascular function is usually maintained.

Deep Sedation/Analgesia: A drug-induced depression of consciousness during which patients cannot be easily aroused but respond purposefully following repeated or painful stimulation. The ability to independently maintain ventilatory function may be impaired. Patients may require assistance in maintaining a patent airway and spontaneous ventilation may be inadequate. Cardiovascular function is usually maintained ....

Richmond Agitation Sedation Scale (RASS): An objective ten-point scoring system to measure drug-induced sedation levels in a patient. This scoring system provides a consistent basis for evaluation and scoring process to determine depth of sedation. The goal of the moderate sedation protocol is to have the patient at level -2 or -3 on the sedation scale where the patient is tranquil and able to respond to commands. The goal of deep sedation is to have the patient at level -4."

According to accessdata.fda.gov related to Ketamine stated 6.5mg per kg IM can produce a sedated state (moderate or deep sedation). Intramuscular doses, in a range of 9 to 13 mg/kg (4 to 6 mg/lb) usually produce surgical anesthesia within 3 to 4 minutes following injection, with the anesthetic effect usually lasting 12 to 25 minutes. According to Patient #20's weight of 68kg (150lbs), a dose of 500mg of Ketamine would result in a moderate to deep sedation effect.

Review of patient #20's ER chart revealed there was no found documentation by the physician or nurse to determine what state of sedation the patient was in. There was no documentation of the RASS score performed. In the triage nurses notes the nurse documented at 12:14PM that Patient #20 was "confused ...unable to respond ... and drowsy under the influence of Ketamine."

Review of the facility's policy and procedure "Management of Moderate and/or Deep Sedation by Non-Anesthesia Personnel" stated,
"Moderate Sedation:
c. Responsibilities of the RN monitoring the patient:
Heart rate , cardiac rhythm and oxygen saturation are monitored continuously. Blood pressure, heart rate, rhythm and pulse oximetry are documented every five (5)minutes, or more frequently depending upon changes in the patient's condition...The patient is monitored for potential adverse reactions to medications being administered. Any signs or symptoms of adverse reactions are to be reported to the physician immediately."

Suicide Severity Rating Scale Review of Patient #20's ED record revealed documentation of vital signs were at 12:21PM. Patient #20 had a documented HR of 140 and a blood pressure of 169/90. There was no documentation that the RN informed the physician of the elevated vital signs. There were no further vital signs taken in the ED from 12:14PM until 8:56PM. There was no documentation that the patient was placed on a heart monitor. The monitor would have shown the ER staff vital signs, O2 saturation, and heart rhythm. A monitor can alarm if there are any inconsistencies with the set parameters. Staff #5 ER Director confirmed on 2/11/22 that the nurse only took one set of vital signs and was not placed on a monitor.

An order was written by the physician to place the patient on a behavioral hold and was ordered for suicidal precautions. The physician ordered a 1:1 at 1:42PM on 1/9/22. The 1:1 was a sitter to observe the patient's behaviors. Review of the sitters "observation Monitoring Tool" revealed the patient had a sitter in place on 1/9/22 at 12:30PM.

Review of the Medication Administration Record (MAR) on 1/9/22 at 1:35PM revealed Patient #20 was administered, Haldol 10mg IM, Ativan 2 mg IM, and Benadryl 50mg IM. Review of the physician progress notes dated 1/9/22 revealed Staff #15 NP had documented under physical exam that the patient was "agitated, States SI" but gave no description of the patient's behaviors to warrant a chemical restraint. There was no nursing documentation that described any behaviors or events that would warrant a chemical restraint. There was no documentation of de-escalation or other behavior modification/restraint attempts. Review of the Sitter's documentation at 1:30PM stated the patient was agitated but no other description of behaviors. The sitter documented at 1:45PM she was calm and lying down. The nurse documented at 1:42PM that she offered food/beverages, toileting, hygiene, exercise/ROM, diversion/ activity. There was no found documentation on vital signs, medication effectiveness, behaviors, or the use of a chemical restraint.

Review of the facility's policy and procedure "Management of Moderate and/or Deep Sedation by Non-Anesthesia Personnel" stated,

"Scope Exclusions:
This policy is not intended or designed for use in sedation of patients on ventilators, or cases such as pain control, control of seizures, postoperative patients, labor analgesia, preoperative medication of patient's when such agents are used to control anxiety, or drug or alcohol withdrawal treatment, or minimal sedation (anxiolysis) as defined below." The facility had no other policy and procedure available to instruct the staff on care after an anesthetic medication was given by EMS. Staff #5 ER Director confirmed on 2/11/22 that the "Management of Moderate and/or Deep Sedation by Non-Anesthesia Personnel" would be the only policy available for moderate or deep sedation observation.


2. Review of Patient #23's chart revealed he was brought to the ED via ambulance on 2/4/22 at 4:05PM. Review of the EMS run sheet written on 2/4/22 at 3:19PM revealed Patient #23 was in jail and EMS had been called for a potential overdose. The EMT documented, "as nurse was starting IV pt was getting very combative swinging around his arms as much as possible for someone wearing wrist ankle cuffs. I attempted coaching the pt and calming him down in a noninvasive way without any success, I administered 400mg ketamine IM which calmed the pt down within a minute or 2 of admin. moved pt over to our stretcher using dark blue sheet under him." The EMT documented that at 4:00PM the patient was given another 100mg of Ketamine IV. There was no reason documented on why the patient was administered the second dose or why it was administered IV.

The nurses ED triage note dated 2/4/22 at 4:05PM stated, "911 call to Stiles (prison) unit for Tegretol OD. Pt reported he took 12- 400mg packets and 30- 200mg pills. Pt is prescribed liquid packet of 400mg PO BID. Stiles nurse, ____ (prison nurses name) unaware of how pt acquired medicine. Report initially called to St. E, but EMS requested to reroute to closet(sic) facility. EMS called report to ED "non-emergent" EMS reported pt became combative enroute -ketamine 400mg IM given and 100mg repeated." Patient #23 had consumed a total of 15,600mg of Tegretol. The patient was handcuffed to the bed and a prison guard was with him. Patient #23 was placed on a behavioral hold and suicide watch.

Review of the physician orders revealed Patient #23 was ordered to be placed on a continuous cardiac monitor, pulse oximetry, and poison control was called concerning the Tegretol (CARBAMAZEPINE). Review of the Patient #23's Physician Discharge Summary dated 2/6/22 stated the patient was taking Tegretol due to a history of seizures.

Review of Tegretol at https://pubmed.ncbi.nlm.nih.gov, Antiepileptic drugs (AEDs), including Tegretol, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication ...Tegretol (CARBAMAZEPINE) Clinical findings in overdose are related to amount of ingestion and blood Carbamazepine level. Coma, hypoventilation, arrhythmias, hemodynamic instability, and even death can occur in Carbamazepine intoxication ...Tegretol overdoses can affect the Nervous System and Muscles by Impairment of consciousness ranging in severity to deep coma. Convulsions, especially in small children. Motor restlessness, muscular twitching, tremor, athetoid movements, opisthotonos, ataxia, drowsiness, dizziness, mydriasis, nystagmus, adiadochokinesia, ballism, psychomotor disturbances, dysmetria. Initial hyperreflexia followed by hyporeflexia."

Review Patient #23's nursing documentation revealed the ED nurse was unable to perform the Columbia Scale (Suicide Severity Rating Scale) due to "patient unable to respond." The nurse also documented on 2/4/22 at 4:39PM the patient was unable to respond due to "sedation." The nurse documented, "pt lying in bed. Respirations even and unlabored. Unable to respond d/t ams, unable to respond to physical stimuli. Guards present in room." There was no documentation of RASS scores or level of sedation.

Patient #23 had vital signs documented every hour in the ED interventions notes but there were no vital signs documented q 5 minutes per the facility's policy and procedure "Management of Moderate and/or Deep Sedation by Non-Anesthesia Personnel." Patient #23 was admitted into the hospital for observation. Staff #5 reviewed the chart with the surveyor and confirmed the findings.

3. Review of Patient #24 revealed she was brought to the ED by EMS on 1/21/22 at 2:14PM. Review of the EMT note dated 1/21/22 at 1:32PM documented,
"...pt was awake and alert, airway patent, wob (sic) non labored, skin good color. strong radial pulses. Pt was not presenting as if he was in any severe pain and no obvious findings in need of immediate life threatening intervention ... PT cooperated after I finished speaking with my supervisor. She walked downstairs with assistance but once we got to the stretcher in the hallway she refused to sit on it. We tried explaining why she needed to be on it numerous times but she wouldn't follow commands. She started pacing around making that hissing noise again, PD assisted her to sit on the foot of the stretcher as I drew up 100mg Ketamine to admin IM left deltoid. Got her secured onto the stretcher. Pt began removing the mask and each piece of medical equipment the moment we would place it on her, we had to use 2 soft wrist restraints to prevent her from doing it any more. we loaded her into the ambulance, got a set of vitals, obtained a 12-Lead EKG and I started an IV gave her another 100mg Ketamine IV, and that calmed her down some but not much, she kept getting her leg, out of the seat belt, kicking them around and flailing her head around So I placed a Pedi Sized C-Collar on her so she wouldn't her us or herself.(sic) Prior to our arrival at the ER I administered another 100mg Ketamine IV due to her removing the pulse ox and she started kicking her legs around again. This 3rd dose sedated her to a GCS of 8. Vitals and mental status as well as her airway were monitored constantly throughout my care of her."

Review of the Nurses notes dated 1/21/22 at 2:08PM revealed the Patient #24 weighed 99lbs (45kg). In a range of 9 to 13 mg/kg (4 to 6 mg/lb) usually produce surgical anesthesia within 3 to 4 minutes following injection, with the anesthetic effect usually lasting 12 to 25 minutes. A dose of 100mg IM and 200mg IV of Ketamine for Patient #24 would result in a moderate to deep sedation effect.

Review of the nurse's notes dated 1/21/22 at 2:14PM the nurse documented, "Pt confused and disoriented, ketamine given by EMS, pt unable to articulate needs, pt attempting to speak but incomprehensible, pt with nystagmus (a condition where you can't control your eye movement), blood drawn, pt straight cathed for urine, covid swab obtained."

Nurse documented at 2:43PM that Patient #24 was "pulling at lines, confusion was impacting care." The physician ordered soft wrist restraints bilaterally and nurse applied them at 2:43PM. Patient #24 was not placed on a cardiac monitor but did have a pulse ox on. Restraints were removed at 3:47PM as patient began to wake. The nurse documented, "Improved mental status grandmother here to pick her up."

Review of the chart revealed Patient #24's vital signs were taken in triage at 2:14PM and at 3:11PM. The patient had no found evidence that the RN was monitoring the patient with

Based on review of records and interview, the facility failed to appropriately identify when a drug or medication was used as a restraint and develop policies and procedures for the safe use, documentation, monitoring of patient, and quality monitoring of drugs or medications used as restraints.

Findings included:

On the morning of 2-10-2022 an interview was conducted with Staff #23 who stated there was a staff member in the Quality Department, Staff #24, that audited all restraints used and provided that information to the Department Directors.

Staff #24 was then interviewed regarding restraints. Staff #24 was asked what kind of restraints were included in the audits. Staff #24 stated that she tracked mechanical restraints, seclusions, and physical holds. When asked about tracking medications, Staff #24 stated that the hospital did not use chemical restraints or medications as a restraint. Staff #24 stated that medications given during a behavioral emergency when the patient was a danger to themselves or others was not a restraint.

Review of the Restraint Data Collection 2021 log showed that it contained aggregated data which included data by the Type (of restraint) Used. One category listed for type of restraint used was "Medication". The log recorded "0" medications used as restraints for the entire year.

Review of patient charts on site showed that patients were receiving medication for behavioral emergencies. Patient #2, Patient #16, Patient #18, and Patient #19 were all found to be given Intramuscular injections of psychoactive medications during behavioral emergencies. One patient was from a 2019 admission, one was from a 2021 admission, and two patients were from 2022 admissions.

Interview was conducted with Staff #2. Staff #2 confirmed that they were not tracking drugs or medications that were being given during a behavioral emergency as a chemical restraint. Staff #2 stated that the Texas regulations prohibited the use of Chemical Restraints. Staff #2 acknowledged that he was aware that Texas regulations allowed for a patient to be given medication during a behavioral emergency when the patient was a danger to themselves or others. However, he was not aware that the State of Texas definition of medications given for a behavioral emergency when a patient was a danger to themselves or others was the same requirements in Federal guidelines for an appropriate use of a medication or drug as a restraint.

Review of Policy Title "Restraint and Seclusion for NON-Behavioral Health Units, Policy Number: POC 41 TEXAS" was written as follows:

"Policy
It is the policy of Steward Health Care that all patients have the right to be free from restraints or seclusion of any form, imposed as a means of coercion, discipline, convenience or retaliation by staff. As such, efforts are ongoing to afford behavioral health patients care in a restraint-free and seclusion-free environment.

Restraint or seclusion is LIMITED TO EMERGENCIES when there is imminent risk of, and present ability to effect, physical harm to the patient or others and only when less restrictive measures have failed, or after a determination that such alternatives would be inappropriate or ineffective under the circumstances.
...
Scope

This policy addresses restraint and seclusion utilized in non-behavioral health units only. For Behavioral Health Units refer to hospital policy for Restraint and Seclusion for Behavioral Health Units.

Definitions
...
b. Violent or Self-Destructive Restraint is the restriction of patient movement for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others.
...
f. Chemical Restraint is the use of any chemical, including pharmaceuticals, through topical application, oral administration, injection, or other means, for the purpose of restraining an individual and which is not a standard treatment for the individual's medical or psychiatric condition. Chemical restraints are prohibited.





Review of Policy Title Restraint and Seclusion - Texas Behavioral Health Units, Policy number: (blank), Origination Date: 3/10/2021 was made as follows:

"Policy
It is the policy of Steward Health Care that all patients have the right to be free from restraints or seclusion of any form, imposed as a means of coercion, discipline, convenience or retaliation by staff. As such, efforts are ongoing to afford behavioral health patients care in a restraint-free and seclusion-free environment.

Restraint or seclusion is LIMITED TO EMERGENCIES when there is imminent risk of, and present ability to effect, physical harm to the patient or others and only when less restrictive measures have failed, or after a determination that such alternatives would be inappropriate or ineffective under the circumstances.
...
Scope

This policy applies to all inpatient psychiatric units. For Non-Behavioral Health Units refer to hospital policy for Restrain and Seclusion for Non-Behavioral Health Units.

Definitions
...
Behavioral Emergency: A situation involving an individual who is behaving in a violent or self-destructive manner and in which preventive, de-escalative, or verbal techniques have been determined to be ineffective and is immediately necessary to restrain or seclude the individual to prevent:
1. imminent probable death or subsequent bodily harm to the individual because the individual is attempting to commit suicide or inflict serious bodily harm; or
2. imminent physical harm to others because of acts the individual commits.

Chemical Restraint: The use of any chemical, including pharmaceuticals, through topical application, oral administration, injection, or other means, for the purpose of restraining an individual and which is not a standard treatment for the individual's medical or psychiatric condition. Chemical restraints are prohibited.
...
Emergency Medication: A psychoactive medication that is used to treat the signs and symptoms of mental illness in a psychiatric emergency, when other interventions are ineffective or inappropriate.
...
Psychiatric Emergency: A situation in which, in the opinion of the physician, it is immediately necessary to administer medication to ameliorate the signs and symptoms of the patient's mental illness and to prevent:
1. Imminent probable death or substantial bodily harm to the patient because the patient:
a. is threatening or attempting to commit suicide or serious bodily harm; or
b. is behaving in a manner that indicates that the patient is unable to satisfy the patient's need for nourishment, essential medical care or self-protection; or
2. Imminent physical or emotional harm to others because of threats, attempts, or other acts the patient makes or commits.
...
Restraint: The use of any medication/chemical restraint, personal restraint or mechanical restraint that immobilizes or reduces the ability of the individual to move his or her arms, legs, body, or head freely
...
PROCEDURE
...
E. Emergency Medication Orders
1. If a physician issues an order to administer psychoactive medication to a patient without patient's consent because of a psychiatric emergency, then the physician will document in the patient's clinical record in specific medical or behavioral terms:
a. why the order is necessary:
b. other generally accepted, less intrusive forms of treatment, if any, that the physician has evaluated but rejected; and
c. the reason those treatments were rejected."


Policy Title: Use of NOW Psychoactive Medications, Policy Number BH-6 under the section "Documentation and Monitoring" was written as follows:

"1. If the patient DOES NOT consent to emergency NOW medication administration, and a physical hold is required, the medication must be documented on the "NOW Medication Log". A physical hold is considered a restraint and must be documented as such according to the Restraint and Seclusion policy, inclusive of a Face to Face examination within 1 hour."

The definitions and procedures outlined in the policies were conflicting and left room for confusion for staff. The procedures above left room to interpret that if a patient agreed to willingly take the medication that had been ordered by the physician, a psychiatric emergency requiring medication was not a restraint. And, if the patient refused to take the medication willingly requiring the staff to hold the patient in order to give the medication, only the hold was classified as a restraint.

While the policy language was reflective of the language used in the Texas Administrative Code, it did not reflect that the language outlining criteria for ordering a medication in a behavioral emergency was the same as the Federal guidelines for giving medication as a restraint. A review of the language in the Texas Administrative Code below showed that a drug or medication used as a restriction to manage the patient's behavior to ensure the immediate physical safety of the patient, a staff member, or others was an approved practice in the Texas Administrative Code but was not referred to as a Chemical Restraint.


TITLE 25 HEALTH SERVICES
PART 1 DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 415 PROVIDER CLINICAL RESPONSIBILITIES--MENTAL HEALTH SERVICES
SUBCHAPTER A PRESCRIBING OF PSYCHOACTIVE MEDICATION
RULE §415.8 Emergency Use of Psychoactive Medication

(a) Emergency psychoactive medications are used to treat the signs and symptoms of mental illness in a psychiatric emergency when other interventions are ineffective or inappropriate.
(b) The selection of the medication should take into account the patient's current medication regimen. Using a medication that the patient is currently prescribed is preferable, if clinically indicated.
(c) All required documentation will be entered into the patient's record as soon as the emergency abates.

SUBCHAPTER F INTERVENTIONS IN MENTAL HEALTH SERVICES
RULE §415.255 Prohibited and Restricted Practices

(a) The following practices are prohibited:
(1) a personal or mechanical restraint shall not be used that:
...
(2) a chemical restraint.

TITLE 25 HEALTH SERVICES
PART 1 DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 414 RIGHTS AND PROTECTIONS OF PERSONS RECEIVING MENTAL HEALTH SERVICES
SUBCHAPTER I CONSENT TO TREATMENT WITH PSYCHOACTIVE MEDICATION--MENTAL HEALTH SERVICES
RULE §414.410 Psychiatric Emergencies

(a) Nothing in this subchapter is intended to preclude the administration of psychoactive medication to any patient in a psychiatric emergency.

Based on review of records and interview, the hospital and governing board failed to ensure that the Quality Department provided ongoing tracking, trending, and analysis data of incidents submitted in the Incident Reporting System to the Patient Safety Triage Team, Quality Improvement Committee, Medical Executive Committee, and Board of Trustees. This information would be necessary for these committees to ensure that appropriate corrective actions had been taken and were sustained in the improvement of patient safety. The Incident Reporting System was the primary reporting system for the Patient Safety Program. Information on tracking, trending, and evaluation of incident reports by categories in order to evaluate the effectiveness of the incident reporting system was not available.


Cross Refer to Tag A0315

Based on review of records and interview, the facility failed to ensure that the Quality Department provided ongoing tracking, trending, and analysis data of incidents submitted in the Incident Reporting System to the Patient Safety Triage Team, Quality Improvement Committee, Medical Executive Committee, and Board of Trustees. This information would be necessary for these committees to ensure that appropriate corrective actions had been taken and were sustained in the improvement of patient safety.

Findings included:

A review of the incident reporting system for all incident reports submitted between 11-1-2021 and 2-10-2022 was made. Incidents were assigned a severity level based on the incident. The severity levels listed on the report were:

- no explanation but listed as General Incident Type of Coding Complication
Severity Level 0 - Non-Safety related complaint
Severity Level 1 - Minor
Severity Level 2 - Moderate
Severity Level 3 - Major
Severity Level P3 - Potentially Major
Severity Level 4 - Catastrophic
Severity Level P4 - Potentially Catastrophic

Between 11-1-2021 and 2-10-2022, there were 38 incident reports submitted that had been rated with a Severity Level of 3, P3, 4, and P4. During interview with Staff #23 on 2-11-2022, Staff #23 explained that all Severity Level of 3, P3, 4, and P4 were reviewed by the Patient Safety Triage Team. The last team meeting had been on Wednesday, 2-2-2022. Three incident reports had been submitted after that date and 35 had been submitted between 11-1-2021 and 1-30-2022.

A review of the Patient Safety Triage Team meeting minutes was made. Of the 35 Severity Level of 3, P3, 4, and P4 incident reports submitted between 11-1-2021 and 1-30-2022, 16 incident reports had not been reviewed by the Patient Safety Triage Team as of 2-10-2022.

Review of the Policy Number: RI 30, Incident Reports: General Overview showed that "Adverse Event" was defined as, "per NIAHO Accreditation Requirements, Interpretive Guidelines and Surveyor Guidance for Hospitals an adverse event is defined an (sic) unexpected occurrence or variation that led to death or serious physical or psychological harm. This definition includes the National Quality Forum (NQF) "never or adverse events" that are errors in medical care that are clearly identifiable and serious in their consequences for patients."

The policy, under section "F. Documentation in the Incident Report", "9. Categorization of the incident" stated that "i. Designate the LEVEL OF PATIENT INJURY and SEVERITY as defined within the online reporting system. Classification of SEVERITY will include near miss or potential harm categories resulting in an increased length of stay."

Incident reports for the Emergency Department submitted between 12-24-2021 and 2-9-2022 were selected for review during the survey. There were 16 incident reports of which 4 reports (25%) involved patients being sent to the Labor and Delivery Department inappropriately. Two reports were classified Severity Level 1 - Minor, one was classified Severity Level 2 - Moderate, and one was classified as Severity Level P3 - Potentially Major. This data was not being tracked or trended by the Patient Safety Triage Team or Quality Improvement Committee.

Review of minutes from the Patient Safety Triage Team, Quality Improvement Committee, Medical Executive Committee, and Board of Trustees meetings was made. No information was included in the meeting minutes on the tracking of medical errors and adverse events, analysis breakdown of their causes, or feedback/learning/corrective actions that were implemented throughout the hospital. Staff #23 confirmed during interview on 2-11-2022 that meeting minutes from the Patient Safety Triage Team were not reported to any other committees.

Without tracking, trending, and analysis of incidents reported through the incident reporting system, no objective evidence was available to show that the incident reporting system was capturing/identifying trends in incidents, possible problems with processes or systems, and corrective actions with monitoring had been put in place to ensure that identified trends had been corrected.

Based on review of records and interview, the Board of Trustees (governing board) failed to provide adequate resources in the form of trained, experienced, or knowledgeable staff to effectively measure and assess potential risks to patients reported through the incident reporting system. The Incident Reporting System was the primary reporting system for the Patient Safety Program. Information on tracking, trending, and evaluation of incident reports by categories in order to evaluate the effectiveness of the incident reporting system was not available.

Findings included:

An interview was conducted with Staff #23 on the morning of 2-10-2022. Staff #23 stated she had been the Director of Quality and Risk for approximately 2 months. Review of documentation provided by Human Resources (HR) showed that Staff #23 had been hired in January 2021 as the Manager of Risk Management. Staff #23 stated that when she started, there were 958 Incident reports that were open and not fully investigated.

Staff #23 reported that the Quality/Safety Department, which included Risk Management, had been furloughed for 8 months. Staff #23 stated they previously had a staff of 12 and now only had a staff of 4. Review of documentation from HR showed that the department was currently without 5 positions filled. Staff #23 was unable to provide an explanation as to why the department had been furloughed.

During meetings with the Chief Executive Officer and Chief Nursing Officer on 2-11-2022, neither could explain why the Quality Department with Risk Management and Safety Program responsibilities would be furloughed during a pandemic when the potential for adverse patient outcomes and safety event/incidents was increased.

Review of the Quality and Patient Safety Plan "Effective for Calendar Year 2021-2022 Updated February 2021" was made.

The Quality Improvement and Patient Safety Risk Assessment identified that the Quality Management staff had been furloughed for 6 months. It was assessed as follows:

"Probability of event, outbreak, system failure, or compliance" as "4 Expect it".
"Risk/Impact Associated with Event (Health, Financial, Legal, Regulatory)" as "4 Temp loss of function"
"Organization's Current Level of Preparedness to Address Risk" as "3 Fair"

Minutes of the Quality Management Oversight Committee meeting minutes for July 21, 2021 reported the following:
"____ (Staff #23) informed the committee as of today 452 incidents in the RL system were open from 2021 and 97 remain open from 2020."

No discussion was documented in the meeting minutes under the heading Recommendations/Actions/Outputs as to the analysis of the types of incidents outstanding, reasons they were not completed, barriers to completing them, and/or actions necessary and time-frame for completion.

Staff #23 was asked how the incidents were tracked, trended, analyzed and how the analysis information was presented through committees to ensure the incident reporting system was effective, incidents were being appropriately reported and classified, and investigations were completed in a timely manner. Staff #23 explained that Severity Level 3 and Severity Level 4 (major and catastrophic) cases were reviewed by the Patient Safety Triage Team. However, no tracking, trending, or analysis of the types of reports received or time frame from reporting to investigation to closure was found. No continuous monitoring was found to ensure that the same type of incidents didn't recur.

Staff #23 stated that she had a notebook where she would write down if an incident was repeated, but this information was not formalized and reported through committees for the committees to discuss potential actions necessary for patient safety.

Incident reports for the Emergency Department submitted between 12-24-2021 and 2-9-2022 were selected for review during the survey. There were 16 incident reports of which 4 reports (25%) involved patients being sent to the Labor and Delivery Department inappropriately. Two reports were classified Severity Level 1 - Minor, one was classified Severity Level 2 - Moderate, and one was classified as Severity Level P3 - Potentially Major. This data was not being tracked or trended by the Patient Safety Triage Team or Quality Improvement Committee. No data trending was available that analyzed incident reports for trends such as department, severity, process problems, etc.

Review of minutes from the Patient Safety Triage Team, Quality Improvement Committee, Medical Executive Committee, and Board of Trustees meetings was made. No information was included in the meeting minutes on the tracking of medical errors and adverse events, analysis breakdown of their causes, or feedback/learning/corrective actions that were implemented throughout the hospital. Staff #23 confirmed during interview on 2-11-2022 that meeting minutes from the Patient Safety Triage Team were not reported to any other committees.

Without tracking, trending, and analysis of incident reports, no meaningful data could be provided that problems were effectively addressed when identified by the incident reporting system.

Review of incident reporting system showed that between 11-26-2021 and 1-30-2022, there were 15 incidents open that had been classified as Severity Level 3 and Severity Level 4 (major and catastrophic) that had not been reviewed by the Patient Safety Triage Team.

No information was found in the Medical Executive Committee meeting minutes or Board of Trustees Meeting minutes that tracked, trended, and analyzed the Incident Reporting System reports to ensure that reports were investigated and resolved in a timely manner with monitoring to ensure patient safety problems identified remained corrected.


Review of the Policy Title: Board of Trustees Bylaws, Final Approval Date: 11/12/2019 was made. Section 3.11 Responsibilities was reviewed as follows:

"The Board shall be delegated responsibilities for the functions enumerated below and related to functions, subject to corporate policies, these bylaws and directives from the Corporation.

The Corporation also reserves the right to intervene and participate in all matters entrusted to the Board, and to amend or replace these bylaws as further provided in Article 11 herein.

The responsibilities and obligations of the Board shall include:
...

3.11.(d) Establishing, maintaining and supporting, through the CEO and the Medical Staff and its designated committees a comprehensive, hospital-wide program for ; receiving reports of information on a regular basis from the Medical Staff, and assuring that all aspects of the program are performed appropriately and that administrative assistance is available to the Medical Staff."

Section 8.1 Board Responsibility for the Quality of Professional Services was reviewed as follows:

"The Board shall complete an annual evaluation of the Hospital Quality Management Program effectiveness based on annual Quality management priorities as established by the Board. The Board, through the CEO, shall provide whatever assistance is reasonably necessary to support and facilitate activities contributing to continuous ."

Review of the Medical Staff Bylaws, Section 11.10 Quality Improvement Committee was made as follows:

"11.10 (a) Composition
The Quality Improvement Committee shall consist of such voting physician members as may be designated by the MEC (medical executive committee). Hospital voting members shall include representatives from Health Information Management, social services/discharge planning, performance improvement/quality management, case management/utilization review, nursing, business office and the CEO or his designee. Hospital voting members may vote on all activities, with the exception of peer review.

11.10 (b) Functions
...The duties of the Quality Improvement Committee shall include, but not be limited to:
(1) ...
(2) monitoring the quality assurance, patient safety, and patient satisfaction activities of the Hospital's section, and committees;"

Review of the Quality and Patient Safety Plan "Effective for Calendar Year 2021-2022 Updated February 2021" was made. The plan contained a Quality Improvement and Patient Safety Risk Assessment broken down by "Program Components".

The Program Component labeled QM.4 SR.1, "The organization shall clearly outline its methodology, practice and related policies for addressing how quality and performance are measured, monitored, analyzed and continually improved with the goal of positice (sic) health outcomes and reduced risk for patients." identified as a problem through their risk assessment that the Quality Management staff had been furloughed for 6 months. The Risk Assessment evaluated the risk as follows:

The risk area categorized as "Probability of event, outbreak, system failure, or compliance" was assessed as a risk level "4 Expect it".

The risk area categorized as "Risk/Impact Associated with Event (Health, Financial, Legal, Regulatory" was assessed as a risk level "4 Temp loss of function"

The risk area categorized as "Organization's Current Level of Preparedness to Address Risk" was assessed as a risk level "3 Fair"

Section D. Quality Improvement & Oversight Committee (QIC) was reviewed as follows:

"The QIC membership includes the Hospital Chief Medical Officer, lay members of the Board of Trustees, administrative leadership, representatives of the Medical Staff and others as deemed appropriate. The QIC has responsibility delegated from the Board and MEC for the following:
...

3. Patient Safety: See Patient Safety Plan (aka Risk Management Plan). The QIC oversees the hospital-wide patient safety program to insure (sic) the scope of the program includes the full range of safety issues, from potential or no-harm errors to hazardous conditions and sentinel events. As part of medical error reduction:
a. The QIC sets the expectation that there is measurable improvement in indicators including but not limited to occurrence screens and quality measures, etc.(see Steward Health Care System Quality and Safety Indicators) with a demonstrated link to the reduction of medical errors.
b. The QIC oversees the Internal Incident Reporting System to ensure all health care providers and hospital staff report injuries, patient complaints and incidents via the hospital reporting system(s). The process includes analysis and trending of reported information and distribution to appropriate stake holders including the Hospital Board. The QIC sets the expectation that there is effective analysis and corrective actions for medical errors and near misses ...


Review of Policy Number: RI 30, Incident Reports: General Overview was made as follows:

"Policy
Any event which is not consistent with the desired care of a patient or the customary operations of the hospital, regardless of whether harm has occurred, should be reported as soon as possible to the immediate supervisor and to the Risk Manager (at a minimum). Department of Quality and Safety (Q/S) ensure timely investigation and corrective action plans, as well as timely reporting to regulatory and accrediting agencies, and to patient and/or family.

Scope
...
The purpose of this policy is to ensure that the Hospital responds to all incidents in a timely, consistent and effective manner. This includes insuring timely attention of senior leadership with regard to any serious incidents (Reportable Event, Sentinel Event or Serious Reportable Event), as well as involvement of Hospital Quality and Safety staff as a point of contact for all incidents.

The goal of effective incident management is to minimize the likelihood of recurrence and hence build a more resilient safety system. Every incident will activate an appropriate investigation and response.

Definitions
...

Incident: An undesirable and unexpected event, which has actual, potential or perceived adverse impact on a patient or visitor. (Requires Investigation and May Require Corrective Action)

Based on observation and interview the facility failed to ensure cleanliness in the Emergency Department (ED) to prevent the transmission of infectious diseases within the hospital.
A tour was conducted in the ED with Staff #1,3, and 5 on 2/9/22 at 1:28PM. The following items were found:

Radiology Room
The floor was extremely soiled with large amounts of dust balls, hair, dirt, and trash.

Around the base of the Xray table a buildup of dirt, a yellow sticky substance, and hairwas found. The surveyor was able to remove the thick substance with a paper towel.

2 portable Xray machines were in the Radiology room. The machines were covered in heavy dust, dirt, and hair.

The equipment against the wall that hold the upright films was covered in dust, dirt, and hair.

The laminate countertop was chipped and missing. Exposed wood was underneath
.

Patient Room 23
Patient Room 23 was designated as a clean room ready for a new patient. Staff #5 confirmed the room was clean and ready for use.

The floor was soiled with dirt, dust, and hair.

A monitor and keyboard were found hanging from the wall. The keyboard stand was soiled with dirt, dust, old tape, and stickers that were torn and soiled.

The stretcher bed was soiled with dust, dried blood, pieces of foil and plastic syringe caps. The plastic base of the bed was cracked and broken. The bed had soiled siderails. The rails were soiled with old tape and dried blood.
The curtains in the room were soiled with dirt, dust, and dark dried blood. The netting on top was torn and soiled.


ER Hallway
2 computer on wheels (cow) were found in the hallway. The Rubbermaid COW was heavily soiled with dirt and dust. The wheels were impacted with dirt and grime. The Growtron COW was heavily soiled with dirt and dust. The wheels were impacted with dirt and grime. The base of the cow was soiled with dried splattered liquids.

The flooring under the corner of the nurse's desk was ripped and split. The floor was unable to be cleaned properly.

8 ER rooms had glass doors that slide on bottom tracks. The tracks were caked with black grime, dirt, hair, plastic caps, trash, and hair. The doors were soiled with dried liquids.


Mental Health Authority Desk Area
A section of the ED had an open area with a desk and chair. The area was for the Mental Health Authority staff to interview and work on patient placement. The area had a patient lift that was in the corner soiled with dirt and dust. A dirty broom was lying next to it and a broken dirty wheelchair. Two bags of patient clothes and towels were found behind the desk. There was no name on these items. Trash was found lying behind the desk on the floor.

ED Patient Room/Treatment Room
ED treatment room had bulbs burned out in the overhead light fixture making it difficult to see.

The blood pressure stand was soiled with dust and hair. It had a sticker on it stating it was a clean item.

The sink was separated from the wall.

The curtains were soiled with dirt, dust, and unidentified spots. The netting on top was torn and soiled.

The bedside table was soiled with dried liquids and patient supplies were laying out on the table.

The floor under the bedside table was soiled with dust, dirt, and hair.


Triage Room B
The weight scale equipment and floor were soiled with heavy dust and hair.

The blood pressure cuff was soiled with blood along with the caddy and base of the machine.

The bottom of the sink was not sealed off. A shelf under the sink was heavily soiled with dirt, trash, dust, and dead bugs. A bottle of cleaner was on the shelf and accessible to patients.

The top of the counter had a plastic tub of clean urine cups for urine samples. The nurse had her personal bag from home laying on top of the urine cups. The bag had food, a drink cup, and personal items in it.

The computer on wheels was heavily soiled with dirt, dust and hair.

A recliner/lounger was found for patient use. The chair was laid back and a large amount of dried blood was found down the arm of the chair. There was trash, dirt, and old food in the chair.

A second tan recliner chair was found to be heavily soiled with dried liquids, trash, hair, and dirt in the creases of the chair.

The bedside table was torn and chipped. A roll of dirty tape was found hanging from the table.

The vinyl rolling divider was found to be soiled and stained with dried liquids.

An interview was conducted with Staff #5 and #3 on 2/9/22 at 1:45PM. Staff #5 confirmed that they did not have enough housekeeping staff to ensure the cleanliness of the ED. Staff #3 also stated that they had been short on staff and have had a hard time retaining the housekeeping staff. Staff #3 and #5 confirmed the findings.