St Francis Community Hospital

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 46745 . Based on observation, interview, and document review, the hospital failed to protect and promote patients’ rights related to care in a safe setting and restraint use. Failure to protect and promote each patient’s rights risks patients’ safety, loss of personal freedom and dignity, and physical and psychological harm. Findings included: Failure to follow the manufacturer’s recommendations for use places patients and staff at risk for injury, harm, or even death. Cross Reference: A 0144 Failure to ensure restraints are imposed for only immediate physical safety places patients at risk for physical and psychological harm and loss of dignity and is a violation of patient rights. Cross Reference: A 0154 Failure to ensure that staff follow approved policies and procedures for restraint use risks severe physical and psychological harm, loss of dignity, and is a violation of patient rights. Cross Reference: A 0160 Failure to adopt and implement policies and procedures for the administration of emergency medications, including obtaining a 2nd medical opinion, puts patients at risk for violation of their rights, risk of psychological harm, and loss of personal dignity. Cross Reference: A 0167 Failure to obtain a physician’s written restraint order places patients at risk for serious physical or psychological harm due to inappropriate application of restraint or restraint type. Cross Reference: A 0168 Failure to ensure that staff discontinue the use of restraints to the least restrictive intervention risks serious physical and psychological harm and loss of dignity and is a violation of patient rights. Cross Reference A: 0174 Failure to ensure medical staff completes restraint and seclusion training risks patient injury or a decline in the patient’s condition due to improper application, assessment, or removal. Cross Reference: A 0176 Failure to perform the required face-to-face evaluation to determine whether the patient meets the specific criteria for restraints and is not suffering from other underlying conditions places patients at risk of harm, injury, or other decline in status. Cross Reference: A 0178 Due to the cumulative effect of these findings, the Condition of Participation at 42 CFR 482.13 Patient Rights was NOT MET. .”

“PATIENT RIGHTS: CARE IN SAFE SETTING CFR(s): 482.13(c)(2) The patient has the right to receive care in a safe setting. This Standard is not met as evidenced by: 46745 . Based on observation, interview, and document review, the hospital failed to ensure staff followed the manufacturer’s recommendation for restraint limb holders in 2 of 8 patients (Patient #3 and Patient #5). Failure to follow the manufacturer’s recommendations for use places patients and staff at risk for injury, harm, or even death. Findings included: 1. Document review of the hospital’s policy titled, “Restraint and Seclusion Policy, 964.00,” PolicyStat ID 12719679, last approved 12/2022, showed that restraints must be applied per the manufacturer’s instructions. Document review of the manufacturer’s instruction for use titled, “Posey Limb Holders 2530, 2540, 25281 Application Instructions for wrist and ankle,” I9209 rev. B 112918, showed that: a. Posey limb holders are soft limb holders used to limit patients at risk of disrupting life-saving treatments (pulling tubes or lines) or in danger of injury to themselves or others. b. Do not use this device on someone who has continued highly aggressive or combative behavior, self-destructive behavior, or is deemed to be an immediate risk to self or others. Document review of the manufacturer’s “PROCARE Personal Limb Holder,” no date, showed the following: a. Intended use is for patients at risk for disturbing medical treatment by pulling their IV line and/or catheter or who are prone to self-injury. b. This restraint is not designed for use on combative or agitated patients. Document review of the manufacturer’s instruction for use title, “ Posey Twice as Tough Cuffs 2792, 2793, 2798, 2799 Application Instructions for Wrist or Ankle,” I9266 rev. D 06/23 showed that: a. Posey Twice as Tough Cuffs are padded limb restraints with double-security closure. b. Intended use for patients assessed to be at risk of disrupting life-saving treatments (chronic tube pulling) or in danger of injury to themselves or others. No contraindications for use. 2. On 04/26/24 from 2:00 PM to 4:30 PM, a medical record review was conducted with the Nurse Educator (Staff #1). The review showed that: a. On 04/01/24 at 8:20 PM, Patient #3 ripped off their face mask, took the wire from it, and attempted to leave the hospital. A Code Gray (response team activation for aggressive or potential combative situations) was called by staff. The registered nurse’s (RN) note showed that the RN explained to Patient #3 the reason to remain in the hospital. Patient #3 was not combative or aggressive towards staff when returning to the patient room. b. The record showed that the provider ordered violent restraints using soft left and right wrist restraints and a posey vest on 04/01/24 at 8:26 PM. The investigator found no evidence of an order clarification for restraint type for violent restraint. c. On 04/19/24 at 5:02 PM, Patient #5 arrived at the emergency department with homicidal thoughts, assaulting the ambulance staff and attempted assault to hospital security. The provider ordered violent restraints using soft left and right wrist restraints and soft left and right ankle restraints. The restraint flow sheet showed that Patient #5 was in locked cuffs, left and right wrist, and left and right ankle restraints. The investigator found no evidence that the RN contacted the ordering provider to clarify the use of restraint type for the restraint orders. 3. Staff #1 stated that applied restraint was based on the provider’s order. Staff #1 confirmed the investigator’s findings of soft limb restraint orders for violent restraint use for Patient #3 and Patient #5. 4. On 04/30/24 at 9:50 AM, the investigator interviewed an emergency department (ED) RN (Staff #5) about the restraint use for violent patients. Staff #5 stated that soft wrist restraints are not used for patients with violent behavior. If the provider writes a violent restraint order with soft restraints, the RN must get a new order from the provider. .”

“USE OF RESTRAINT OR SECLUSION CFR(s): 482.13(e) Patient Rights: Restraint or Seclusion. All patients have the right to be free from physical or mental abuse, and corporal punishment. All patients have the right to be free from restraint or seclusion, of any form, imposed as a means of coercion, discipline, convenience, or retaliation by staff. Restraint or seclusion may only be imposed to ensure the immediate physical safety of the patient, a staff member, or others and must be discontinued at the earliest possible time. This Standard is not met as evidenced by: 46745 . Based on document review, medical record review, and interview, the hospital failed to ensure restraints were imposed only for the immediate physical safety of the patient or staff member in 1 of 9 patient records reviewed (Patient #9). Failure to ensure restraints are imposed for only immediate physical safety places patients at risk for physical and psychological harm and loss of dignity and is a violation of patient rights. Findings included: 1. Document review of the hospital’s policy and procedure titled, “Notice of Patients’ Rights and Responsibilities on Admission, 390.00,” PolicyStat ID 10140777, last approved 07/21, showed the following: Patients have the right to be free from restraints and seclusion in any form that is not medically necessary or used as a means of coercion, discipline, convenience, or retaliation by staff. Document review of the hospital’s policy and procedure titled, “Restraint and Seclusion Policy, 964.00,” PolicyStat ID #12719679, last approved 12/22, showed the following: a. Limit restraint and seclusion to situations where it is necessary to ensure the immediate physical safety of the patient, staff members, and others with appropriate assessment. b. The hospital does not use restraints or seclusion as a means of coercion, discipline, convenience, or staff retaliation. c. Remove restraints from the patient’s room when not in use. 2. On 04/26/24, the investigator reviewed the hospital’s security team’s Disruptive Behavior Patient Log records dated 01/31/24 to 04/26/24. The review showed that hospital security was contacted on 04/16/24 at 4:23 PM to complete a screen and assist with restraint application in the emergency department (ED). The security incident report showed that Patient #9 was not following the registered nurse’s (RN) directions and experiencing hallucinations of spiders crawling on them, causing pain, and wanting to leave. The report showed that Patient #9 agreed to stay and follow directions. The document showed that the security officer stated that the restraints were left on Patient #9’s bed “just in case” and that, “the restraints helped in a way that the patient would listen to staff.” 3. Medical record review showed that on 04/16/24 at 4:51 PM, the ED provider evaluated Patient #9 for hallucinations. At 4:54 PM, the record showed that the restraints were placed on the bed, not on Patient #9. 4. On 05/01/24, from 10:30 to 11:00 AM, the investigator interviewed the ED Nurse Educator (Staff #4) about restraint use. Staff #4 stated that restraints should not be left in the room when not being used. .”

“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: 46745 . Based on record review, interview, and review of hospital policy and procedures, the hospital failed to ensure that patients do not receive chemical restraints, as directed by hospital policy in 1 of 2 patients (Patient #3) Failure to ensure that staff follow approved policies and procedures for restraint use risks severe physical and psychological harm, loss of dignity, and is a violation of patient rights. Findings included: 1. Document review of the hospital’s policy and procedure titled, “Restraint and Seclusion Policy, 964.00,” PolicyStat ID #12719679, last approved 12/22, showed the following: a. A restraint is any physical or chemical method, mechanical device, or equipment that immobilizes or reduces a patient’s ability to move or access any body part. b. The hospital uses the least restrictive form of restraint or seclusion to protect the physical safety of the patient, staff, or others. c. The hospital does not use restraints or seclusion as a means of coercion, discipline, convenience, or staff retaliation. d. Chemical restraint is not a standard use of medication to treat a patient’s medical or behavioral condition. Virginia Mason Franciscan Health (VMFH) does not use chemical restraint. 2. On 04/26/24 from 2:00 PM to 4:30 PM, the investigator conducted a medical record review with the Nurse Educator (Staff #1). The record review showed the following: a. On 04/04/24 at 7:15 PM, Patient #3 was involuntarily detained for 90 days while waiting for mental health placement. The medical record showed that a Code Gray was called when Patient #3 attempted to elope. The medical record showed that emergency department (ED) physicians responded to the code gray and found Patient #3 on the ground, restrained by 8 staff members. Staff were unable to redirect Patient #3. The ED physician ordered haloperidol lactate 5 milligrams (mg) and diphenhydramine 50 mg intramuscularly (IM). 3. On 04/26/24, from 9:35 AM to 9:50 AM, the investigator conducted an interview with a registered nurse (RN) (Staff #11) on 3 Med-Telemetry Unit. Staff #11 stated that chemical restraints are administered on the unit and described an example of a behavior treated with chemical restraints. The RN and the provider discussed the patient’s behavior, and the provider ordered medication if necessary. Staff #11 stated that the RN monitored the patient’s heart rhythm or oxygen saturation monitoring for side effects after the medication was administered. 4. At 10:00 AM, the investigator conducted an interview with a hospitalist (Staff #12). Staff #12 stated that chemical restraints are prescribed based on the patient’s behavior. They may be given to dementia patients or more agitated patients. Psychiatric patients may need a low dose of medication. 5. On 04/26/24 at 10:10 AM, the investigator interviewed the Nurse Educator (Staff #1) about using chemical restraints. Staff #1 stated that the hospital’s policy does not permit chemical restraints. . .”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(4)(ii) [The use of restraint or seclusion must be--] (ii) implemented in accordance with safe and appropriate restraint and seclusion techniques as determined by hospital policy in accordance with State law. This Standard is not met as evidenced by: 46745 . Based on interviews, record reviews, and a review of hospital policies and procedures, the hospital failed to adopt and implement policies and procedures for obtaining a second medical opinion following the administration of emergency antipsychotic medications in 2 of 2 records reviewed (Patient #3 and Patient #5). Failure to adopt and implement policies and procedures for obtaining a 2nd medical opinion following the administration of emergency antipsychotic medications puts patients at risk for violation of their rights, risk of psychological harm, and loss of personal dignity. Findings included: 1. Document review of the hospital’s policy titled, “Antipsychotic Medication Administration Policy, 723.00,” PolicyStat 10428035, last approved 11/21, showed the following: When a patient is prescribed an unfamiliar anti-psychotic medication, the physician/provider will provide adequate information assuring informed consent. a. The physician/provider may administer anti-psychotic medications over the patient’s objection or lack of consent only in the following circumstances: i. The patient presents an imminent likelihood of serious harm to self or others, and ii. Medically acceptable alternatives to the administration of antipsychotic medications are not available or unlikely to be successful, and iii. In the physician’s opinion, the patient’s condition constitutes an emergency requiring treatment before obtaining a second opinion from a non-attending physician. iv. A second physician will review the decision to administer antipsychotic medication in an emergency within 24 hours. Document review of the hospital’s policy and procedure titled, “Restraint and Seclusion Policy, 964.00,” PolicyStat ID #12719679, last approved 12/22, showed that a restraint is any physical or chemical method, mechanical device, or equipment that immobilizes or reduces a patient’s ability to move or access any body part. 2. Medical record review showed that on 04/04/24 at 7:15 PM, Patient #3 was involuntarily detained for 90 days while waiting for mental health placement. The medical record showed that a Code Gray was called when Patient #3 attempted to elope. The medical record showed that the emergency department (ED) physicians responded to the code gray and found Patient #3 on the ground, restrained by 8 staff members. Staff were unable to redirect Patient #3. The ED provider ordered haloperidol lactate 5 milligrams (mg) and diphenhydramine 50 mg intramuscularly (IM). The investigator found no documentation showing that a second physician completed a review of the decision to administer emergency antipsychotic medication within 24 hours as required by hospital policy. 3. Medical record reviewed showed that on 04/19/24 at 5:02 PM, Patient #5 was involuntarily detained for homicidal thoughts, assaulting the ambulance staff and attempted assault to hospital security. Provider documentation showed that Patient #5 required restraints and sedation for violent behavior, and the provider placed an order for haloperidol lactate. The investigator found no documentation showing that a second physician completed a review of the decision to administer emergency antipsychotic medication within 24 hours as required by hospital policy. 4. On 05/01/24 from 9:15 AM to 9:30 AM, the investigator interviewed an emergency medicine physician (Staff #6). Staff #6 stated that a second provider review within 24 hours of the administration of emergency antipsychotic medications does not occur and is not required. 5. The investigator interviewed the hospital’s Pharmacy Director (Staff #13) on 05/01/24 from 10:00 AM to 10:15 AM. Staff #13 stated they were unfamiliar with the hospital’s Antipsychotic Medication Administration policy, and the pharmacy does not track, monitor, or review patient records for 2-provider reviews following the administration of emergency antipsychotic medications. Staff #13 stated that the policy may have been used for an inpatient behavioral health unit that is no longer active. 6. On 05/01/24 at 10:15 AM, the investigator interviewed the Regulatory Manager (Staff #10) about the policy requiring a 2nd provider review following the administration of emergency antipsychotic medications. Staff #10 stated that they were not familiar with the policy as an active policy. .”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(5) §§482.13(e)(5) - The use of restraint or seclusion must be in accordance with the order of a physician or other licensed practitioner who is responsible for the care of the patient and authorized to order restraint or seclusion by hospital policy in accordance with State law. This Standard is not met as evidenced by: 46745 . Based on record review, interview, and review of hospital policy and procedures, hospital staff failed to obtain a physician’s order for the correct application of nonviolent and violent behavioral restraints for 6 of 8 restraint patients reviewed (Patient #1, Patient #2, Patient #3, Patient #4, Patient #5, and Patient #6). Failure to obtain a physician’s written restraint order places patients at risk for harm due to inappropriate application of restraint or restraint type. Findings included: 1. Document review of the hospital’s policy and procedure titled, “Restraint and Seclusion Policy, 964.00,” PolicyStat ID 6436707, last approved 12/22, showed that: a. The use of restraints is not driven by diagnosis but by a comprehensive individual patient assessment that includes a physical assessment to identify medical problems that may cause behavior changes. b.Violent or self-destructive and nonviolent or non-self-destructive are terms used to describe behaviors that cause the need for restraint. Order type determines the documentation and monitoring requirements. c. The hospital uses the least restrictive form of restraint or seclusion that protects the physical safety of the patient, staff, or others. d. The registered nurse (RN) may initiate the restraint order if the provider is unavailable during the assessment, indicating the need for restraint and less restrictive measures have failed. e. Nonviolent restraint orders are obtained as soon as possible and valid for one calendar day. Duration cannot exceed the order interval. f. Violent orders must be obtained up to one hour after initiating restraints. They are renewed every four hours for adults and can be renewed by phone for up to 24 hours. g. If the ordering provider is not the attending provider, the attending provider must be consulted as soon as possible. h. Restraint orders must have the following: observed behavior, restraint reason, assessment, less restrictive alternatives attempted, restraint type and location (select laterality and limb), discontinue restraints (choose the time and enter appropriate comments). Patient #1 2. Medical record review showed that on 11/30/22, Patient #1 was placed in a nonviolent posey vest for agitation. At 12:15 PM, the medical provider ordered violent restraints, locking cuffs to the left and right wrist for agitation and physical assault. The restraint flowsheet showed Patient #1 was in a posey vest and locked left and right wrist restraints. At 2:00 PM, the violent restraint flowsheet showed that the locked cuff wrist restraints were discontinued. Patient #1 remained in the posey vest. The investigator found no evidence that violent restraint orders were clarified to include the posey vest. Patient #2 3. Medical record review showed that on 04/12/25 at 4:45 PM, Patient #2 was placed in a nonviolent posey vest restraint for pulling at lines. The medical provider placed an order for nonviolent restraints on 04/12/25 at 4:45 PM. The next order for nonviolent restraints was 04/14/24 at 12:43 PM. The restraint flowsheet showed that Patient #2 remained in the posey vest. Patient #2 was without a nonviolent restraint order for 12 hours and 53 minutes. The investigator found no evidence in the medical record that the staff attempted to contact a provider for a restraint renewal order or discontinue the restraints on Patient #2 after the order expired at 11:59 PM on 04/13/24. Patient #3 4. Medical record review showed that on 03/27/24 at 7:25 PM, Patient #3 was placed in violent locking cuffs on the left and right wrist and left and right ankles and a posey vest for attempting to elope. At 8:14 PM, the medical record showed the RN received a verbal order from the hospitalist for locking cuffs for the left and right wrist and left and right ankles for self-harm. All restraint types were discontinued at 11:11 PM. The hospitalist cosigned the violent restraint order for locking cuffs on 03/28/24 at 6:11 PM. The investigator found no evidence of an additional posey vest order from the hospitalist or that a violent restraint order was completed by a medical provider within the required time frame. Patient #3 was in violent restraints without a correct provider order for a period of 3 hours and 46 minutes. a. On 04/01/24 at 8:26 PM, the provider order showed violent restraints with soft left and right wrist and posey vest. The order listed the observed behavior as “other.” Violent behavior present jeopardizing immediate physical safety of patient/orthers. The medical record showed that a Code Gray was called. b.At 8:45 PM, the sitter flowsheet showed that Patient #3 was in a posey vest, and soft left and right wrist restraints were not started. The investigator found no evidence that the provider’s order at 8:26 PM was clarified for Patient #3’s current type of restraints. Patient #4 5. Medical record review showed that on 04/15/24 at 4:30 PM, Patient #4 was placed in a nonviolent restraint posey vest for agitation. The restraint flowsheet showed that the registered nurse (RN) notified the emergency department provider when the nonviolent restraints were placed. At 7:11 PM, Patient #4 was assigned to the hospitalist team. At 7:17 PM, the RN entered the order that showed a “nonviolent restraint order per protocol; no consign was required.” On 04/16/24 at 6:01 PM, the hospitalist completed a new restraint order for a posey vest. The investigator found no evidence that the attending was notified of the need for restraint orders. The investigator found no evidence that the attending was notified of the need for restraint orders. Patient #5 6. Medical record review showed that on 04/19/24 at 5:02 PM, Patient #5 had attempted to assault staff physically. The provider ordered violent restraints for Patient #5, using soft left and right wrist restraints and soft left and right ankle restraints. The restraint flowsheet showed that Patient #5 was in locked cuffs, left and right wrist, and left and right ankle restraints. The investigator found no evidence that the RN contacted the ordering provider to clarify the violent restraint type. Patient #6 7. Medical record review showed that on 03/29/24 at 6:00 AM, the restraint flowsheet showed that Patient #6 was confused and in soft left and right wrist restraints and a posey vest. At 6:00 AM, the soft left and right ankle restraints were discontinued. On 03/29/24 at 9:46 AM, the provider order showed nonviolent restraints, a posey vest, soft left and right wrists, and soft left and right ankles for impulsive behavior and cognitive impairment. The investigator found no use of the soft left and right ankle restraints in the restraint flowsheet and no evidence of a clarified order for the correct restraint limb location. 8. On 04/30/24 from 2:00 PM to 4:30 PM, the investigator completed an interview with the Nurse Educator (Staff #1). Staff #1 stated that the restraint order cannot have additional restraints ordered if the patient is not currently in that restraint. Staff #1 confirmed the investigator’s findings that hospital staff failed to follow the hospital’s policy and procedures regarding restraint orders. .”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(9) Restraint or seclusion must be discontinued at the earliest possible time, regardless of the length of time identified in the order. This Standard is not met as evidenced by: 46745 . Based on interview, record reviews, and review of policy and procedures, the hospital failed to ensure that staff discontinued restraints at the earliest time that would be effective in protecting the patient, staff member, or others from harm for 5 of 8 patient records reviewed (Patient #1, Patient #2, Patient #3, Patient #4, and Patient #7). Failure to ensure that staff discontinue the use of restraints to the least restrictive intervention risks serious physical and psychological harm, loss of dignity, and violation of patient rights. Findings included: 1. Document review of the hospital’s policy and procedure titled “Restraint and Seclusion Policy, 964.00,” PolicyStat ID #12719679, last approved 12/22, showed the following: a. Appropriate assessment, care, monitoring, and reassessment intervals are based on the patient’s needs, condition, and type of restraint used. b. Every attempt is made to initiate removing the patient from restraints as soon as clinically warranted, no matter the length of the order. This shall be based on observation and assessment that determines that the patient no longer needs the restraint to protect self or others from injury. c. Nonviolent restraint discontinuing criteria are not limited to when lines or tubes are discontinued, the patient’s ability to follow instructions, implement least restrictive alternatives, reduce symptoms warranting restraints, and ambulate more safely. d. Violent restraint and Seclusion discontinuing criteria are not limited to when the patient’s ability and willingness to follow directions, reduction in behavior(s) warranting restraints, ability to implement less restrictive alternatives, ability to redirect behaviors safely, and the ability to agree to a safety plan. e. Nonviolent restraint monitoring occurs at least every 2 hours for correct restraint placement, range of motion, circulation and skin integrity, and emotional well-being. Offer fluids, food, and toileting. f. Violent restraint monitoring is observed every 15 minutes to ensure correct restraint placement, injury prevention, circulation and skin integrity, and emotional well-being. Fluids, food, and toileting are offered every 1 to 2 hours. g. Document at least once per shift in the restraint type section “Continue” if the patient does not meet the restraint removal criteria or “Discontinue” if the patient meets removal criteria 2. On 04/24/24 at 11:10 AM, the investigator interviewed a registered nurse (RN) (Staff #14) on the 1st floor unit about restraint discontinuation. Staff #14 stated that restraints are discontinued when the patient is no longer confused or impulsive. Nonviolent restraints are monitored every 2 hours and documented in the restraint flowsheet. 3. On 04/24/24 from 12:00 PM to 12:15 PM, the investigator conducted an interview with the Nurse Educator (Staff #1) Staff #1 stated that the nurse documents the patient’s progress toward discontinuation in the restraint flowsheet. Documentation is required once per shift. Based on the documentation from the previous shifts, the nurse assesses release criteria throughout the shift. Interventions that have been tried are documented once per shift in the restraint flowsheet or shown in the care plan. Start, continue, and discontinued use is shown in the restraint flowsheet by “restraint type”. Restraints are discontinued when the patient can verbalize release criteria or no longer exhibits the behavior requiring the restraint. The restraint order is discontinued based on the end time entered by the provider. The RN does not discontinue the order. Patient #1 4. Medical record review showed that Patient #1 was brought to the hospital on 11/17/22 after throwing a chair at the caregivers in their community living facility. The record showed that on 11/17/22 at 11:00 PM, Patient #1 was placed in nonviolent soft left and right wrist restraints and a posey vest for agitation and aggression. a. On 11/23/22 from 2:30 AM to 9:00 AM, the restraint flowsheet showed that during the 2-hour monitor checks, the patient was sleeping, but the soft left and right wrist restraints and posey vest use continued. The investigator found no evidence that staff attempted to discontinue the restraints. b. On 11/28/22 from 11:00 PM to 5:00 AM, the restraint flowsheet showed that during the 2-hour monitor checks, the patient was sleeping, but the soft left and right wrist restraints and posey vest use continued. The investigator found no evidence that staff attempted to discontinue the restraints. c. On 11/29/22 at 5:45 PM, the restraint flowsheet showed that Patient #1 was placed in violent restraints, locked cuffs on the left and right wrist, and remained in the posey vest. d. On 11/29/22 from 9:30 PM to 11:04 PM, the violent restraint flowsheet showed that Patient #1 was sleeping during the 15-minute monitor checks, but the locked left and right wrist restraints and a posey vest continued. The investigator found no evidence that staff attempted to discontinue the restraints. Patient #2 5. Medical record review showed that on 04/16/24, Patient #2 was brought to the hospital after aggressive behavior in their community care facility. The record showed that at 7:00 PM on 04/16/24, Patient #2 was placed in a posey vest for agitation and restlessness. On 04/17/24 from 1:00 AM to 5:00 AM, the restraint flowsheet showed during the 2-hour monitor check that the patient was sleeping, and the posey vest use continued. The investigator found no evidence of staff attempting to discontinue the restraints. Patient #3 6. Medical record review showed that on 03/26/24, Patient #3 was brought to the hospital after an intentional ingestion of a foreign object at a community care facility. The record showed that on 04/01/24 at 8:20 PM, Patient #3 was placed in a posey vest for agitation and impulsive behavior and was under continuous observation every 15 minutes. a.At 9:00 PM and 9:15 PM, 15-minute restraint checks showed that Patient #3’s psychological status was “subdued.” b. At 9:30 PM, 9:45 PM, and 10:00 PM, the 15-minute restraint checks showed that Patient #3 was asleep. The investigator found no evidence of staff attempting to discontinue the restraints earlier. Patient #4 7. Medical record review showed that on 04/15/24, Patient #4 was brought to the hospital after aggressive behavior in their community care facility. On 04/15/24 at 4:30 PM, Patient #4 was placed in a posey vest because they could not follow commands and agitation. a. On 04/15/24, at 10:31 PM, the restraint flowsheet showed that Patient #4 was asleep during the 2-hour monitor checks, and the posey vest continued. b. From 10:31 PM to 7:00 AM on 04/16/24, the restraint flowsheet showed no restraint documentation (a period of 8 hours 29 minutes). c. On 04/16/24, from 7:00 AM until 1:00 PM, the restraint flowsheet showed that Patient #4 was asleep during the 2-hour monitor checks, and the posey vest continued. The investigator found no evidence that staff attempted to discontinue the restraints. Patient #7 8. Medical record review showed that on 04/25/24, Patient #7 was brought to the hospital after a fall at the community care facility. The medical record showed that on 04/25/24 at 9:00 PM, Patient #7 was placed in nonviolent soft left and right wrist restraints and a posey vest for pulling at lines. a.The restraint flowsheet did not show evidence that the restraints were monitored from 9:00 PM to 04/26/24 at 8:00 AM (a period of 9 hours). b. On 04/26/24 at 8:00 AM, the restraint flowsheet showed that Patient #7 was agitated and restless, continued in the soft left/right wrist and posey vest restraints. c. On 04/26/24 from 12:00 PM to 3:20 PM, the restraint flowsheet showed the 2-hour restraint monitoring that Patient #7 was asleep but continued soft left and right wrist and posey vest restraints. At 3:30 PM, the soft wrist restraints were discontinued and Patient #7 remained in a posey vest. The investigator found no evidence that staff attempted to discontinue restraints. 9. On 04/30/24 from 12:00 PM to 4:30 PM the investigator completed a medical record review with the Nurse Educator (Staff #1). Staff #1 confirmed the investigator’s findings that hospital staff failed to follow the hospital’s policy and procedures regarding discontinuing restraints as soon as possible. .”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(11) Physician and other licensed independent practitioner training requirements must be specified in hospital policy. At a minimum, physicians and other licensed practitioners authorized to order restraint or seclusion by hospital policy in accordance with State law must have a working knowledge of hospital policy regarding the use of restraint or seclusion. This Standard is not met as evidenced by: 46745 . Based on interview, document review, and review of policy and procedure, the hospital failed to ensure the medical staff received training in the use of restraint and seclusion according to hospital policy for 3 of 3 medical staff training records reviewed (Staff #7, Staff #8, and Staff #9). Failure to ensure medical staff completes restraint and seclusion training risks patient injury or a decline in the patient’s condition due to improper application, assessment, or removal. Findings included: 1. Document review of the hospital’s policy, “Restraint and Seclusion Policy, 964.00,” PolicyStat ID 12719679, last approved 12/22, showed that providers must have a working knowledge of the policy. The policy’s Addendum D showed that Medical staff shall receive training in subjects related to their duties performed under the Restraint and Seclusion Policy. Training shall occur during new employee orientations and periodically as indicated by the results of quality monitoring activities and recommendations from Education Services. 2. On 05/01/24 at 11:15 AM, the investigator interviewed the Regulatory Manager (Staff #10) about the requested provider training records. The review showed that 3 of 3 training records did not contain documentation of periodic restraint education as required by hospital policy (Staff #7, Staff #8, and Staff #9). During the review, Staff #10 confirmed the investigator’s finding of the missing documentation. .”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(12) When restraint or seclusion is used for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others, the patient must be seen face-to-face within 1-hour after the initiation of the intervention -- o By a-- - Physician or other licensed practitioner; or - Registered nurse who has been trained in accordance with the requirements specified in paragraph (f) of this section. This Standard is not met as evidenced by: 46745 . Based on record review, interview, and review of hospital policies and procedures, the hospital failed to ensure that patients placed in violent restraints received a face-to-face assessment within one hour by a provider as directed by hospital policy in 1 of 2 patients reviewed (Patient #3). Failure to perform the required face-to-face evaluation to determine whether the patient meets the specific criteria for restraints and is not suffering from other underlying conditions places patients at risk of harm, injury, or other decline in status. Findings included: 1. Document review of the hospital’s policy and procedure titled, “Restraint and Seclusion Policy, 964.00,” Policy Stat ID number 127196789, last approved 12/22, showed that the provider will perform a face-to-face evaluation within one hour of restraint application that will include the following information: a. Patient’s immediate situation b. Patient’s reaction to the intervention c. The patient’s medical and behavioral condition d. The need to continue or terminate the restraint or seclusion The Registered Nurse (RN) will document “yes” in the violent restraint flowsheet when the provider completes the in-person evaluation. 2. On 04/26/24 at 9:38 AM, the investigator interviewed a 3 Med-Telemetry Unit RN (Staff #11) about violent restraint use. Staff #11 stated that in the violent restraint flow sheet, “yes” was documented when the medical provider was at the bedside to evaluate the patient and showed a completed the face-to-face evaluation. 3. On 04/26/24 from 2:00 PM to 4:30 PM, the investigator completed a medical record review with the Nurse Educator (Staff #1). The medical review showed that: a. On 03/27/24 at 7:25 PM, the RN placed Patient #3 in violent locking bilateral wrist and ankle restraints, and a posey vest. At 8:14 PM, the medical record showed the RN received a verbal order from the provider for locking cuffs for bilateral wrists and bilateral ankles. The investigator found no evidence of a completed provider face-to-face in the restraint flow sheet or in a provider progress note. b. On 04/01/24 at 8:26 PM, the provider placed a new order for violent restraint soft left and right wrist and posey vest. The order showed observed behavior as “other (please describe). The medical record showed a Code Gray called. c. At 8:40 PM, the restraint flowsheet showed that Patient #3 was in a posey vest. The investigator found no documentation of a completed face-to-face on the restraint flowsheet or of a provider progress note. 4. During the review, Staff #1 confirmed that the restraint order showed that Patient #3 was observed with self-harm behaviors and escalated agitation, and the patient’s behavior jeopardized the patient and others. Staff #1 stated that the provider was required to complete a face-to-face evaluation and document it in a progress note. 5. Staff #1 confirmed that the provider face-to-face evaluation were not completed for Patient #3. .”

“PATIENT SAFETY CFR(s): 482.21(a), (c)(2), (e)(3) (a) Standard: Program Scope (1) The program must include, but not be limited to, an ongoing program that shows measurable improvement in indicators for which there is evidence that it will ... identify and reduce medical errors. (2) The hospital must measure, analyze, and track ...adverse patient events ... (c) Program Activities ..... (2) Performance improvement activities must track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the hospital. (e) Executive Responsibilities, The hospital’s governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following: ... (3) That clear expectations for safety are established. This Standard is not met as evidenced by: 46745 . Based on interview, record review, and review of hospital policies and procedures, the hospital failed to follow its policies and procedures for completing Code Gray incident reports (incident reports following Code Gray events) for 2 of 3 patients (Patient #8 and Patient #9). Failure to follow hospital policies and procedures for completing an incident report limits the hospital’s ability to enact measures that prevent or mitigate patient harm. Findings included: 1. Document review of the hospital’s policy titled, “Incident Reporting Information System (IRIS) Guidelines and Management, 418.00,” PolicyStat ID 9305091, last approved 07/21, showed that: a. IRIS reporting facilitates system improvement and promotes a culture of continuous advancement in patient safety. b. An incident is any incident that is inconsistent with a particular patient’s routine care, such as a violation of an established procedure or any other concern or unusual event. c. Catholic Health Initiatives Franciscan Health (CHI FH) encourages reporting all incidents to improve processes and systems, enhance patient safety, and promote quality improvement/assurance. d. An example of an incident is a quality of care concern or issue. e. A patient report should be completed for an event affecting a patient while receiving care during the hospitalization. An example of a patient event is a behavioral event: Code Gray, Elopement, or attempted elopement and assaultive or abusive patient behavior. Document review of the hospital’s policy “Code Gray (Out of Control Behavior) Policy, 907.75,” PolicyStat ID 13037796, rev. 08/23 showed that: a. Code Gray is initiated when a patient exhibits behaviors that are or will become aggressive, hostile, or combative. b. Security will complete a detailed security incident report. c. The Code Gray Team Leader will complete an incident report in IRIS. Security fulfills the role of Team Leader. 2. Medical record review showed that on 04/30/24 from 12:30 PM to 4:30 PM, the investigator reviewed the medical records with the Nurse Educator (Staff #1). The medical record review showed the following: a. On 03/26/24 at 3:14 PM, the registered nurse (RN) documented that while walking in the hallway with a certified nursing assistant (CNA), Patient #8 became agitated, restless, was unable to follow commands and hit the CNA with a walker while attempting to leave the unit. Security was notified to escort Patient #8 back to the room. b. The RN progress note dated 04/07/24 at 6:25 PM showed that hospital security was contacted at 2:00 PM and 5:00 PM to assist with Patient #8’s attempted elopement and agitation. 3. The investigator conducted a document review of the hospital’s security team’s Disruptive Behavior Patient Log records dated 01/31/24 to 04/26/24. The review showed that the following: a. On 04/07/24 at 1:35 PM, security staff responded to a request for assistance with Patient #8 in the inpatient unit. b. On 04/16/24 at 4:23 PM, security staff responded to a request for assistance with restraint replacement for a patient attempting to elope from the emergency department (ED) (Patient #9). 4. On 04/30/24 at 12:00 PM, the investigator interviewed the Patient Safety Specialist (Staff #3) about IRIS event reporting. During the interview, Staff #3 could not find the IRIS event report for Patient #8 for events that occurred on 03/26/24 at 3:14 PM, 04/07/24 at 2:00 PM, or 04/07/24 at 5:00 PM. or for Patient #9 for the event that occurred on 04/16/24 at 4:23 PM. Staff #3 stated that an incident report should have been completed for each event. .”