Providence Regional Medical Center Everett

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 42597 . Based on document review, medical record review, and interview, the hospital failed to promote and protect patient rights. Failure to promote and protect each patient’s rights risks physical and psychological harm, and loss of patient dignity. Findings included: 1. Failure to ensure care in a safe environment. Cross-reference A0144 2. Failure to utilize restraints only for the immediate physical safety of the patient, staff or others. Cross-reference A0154 3. Failure to ensure that use of restraint or seclusion was reflected in the individualized patient treatment plan. Cross-reference A0166 4. Failure to ensure that restraints were discontinued at the earliest possible time. Cross-reference A174 5. Failure to ensure that Registered Nurses (RNs) competently performed 1-hour face to face evaluations required for patients placed in violent restraints. Cross-reference A0196 Due to the scope and severity of deficiencies under 42 CFR 482.13, the Condition of Participation for 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: 42597 . Based on document review, medical record review, and interview, the hospital failed to ensure care in a safe environment for 1 of 1 patients exhibiting violent behaviors (Patient #1). Failure to ensure care in a safe environment for patients, staff, and others places people at risk for injury or death and is a violation of patient rights. Findings included: 1. Document review of a hospital booklet titled, “Helpful Information for Patients and Families,” #39493, dated 12/23, showed that patients have the right to care in a safe setting. 2. On 09/17/24 between 9:00 AM and 11:15 AM, and on 09/27/24 between 9:00 AM and 11:00 AM, the investigator and a Patient Safety Consultant (Staff #1) reviewed Patient #1’s medical record and related documents. The review showed the following: a. On 09/01/23, Patient #1 was brought to the emergency department after allegedly assaulting a family member. Patient #1 was deemed a danger to others and involuntarily detained (legal process forcing mandatory hospitalization for mental health treatment) as an inpatient in a general medical unit. i. Patient #1 had 51 physician orders for violent restraint dated between 10/13/23 at 1:51 PM and 11/08/23 at 4:28 PM. ii. A Nursing note dated 10/21/23 at 7:59 PM, documented that the author had been informed by management 10/20/23 that Patient #1 was to have a security guard stationed outside of the room around the clock, but no security guard was present. The RN spoke with a house supervisor and was told that the Patient #1 was not going to have a security officer assigned. b. A security log report documented the following: i. Between 09/22/23-02/04/24, security officers responded to a total of 18 events involving Patient #1. ii. There were 11 instances of Code Gray (security response for a patient posing a danger to self or others), 7 of which ended in the application of restraints. iii. 8 incidents involved assault, including 3 with injury. c. A scanned document dated 11/09/23 and titled, “Therapeutic Planning for Patient #1,” showed that Patient #1 was to have a security officer stationed outside of the room 24/7. d. At the time of the review, Staff #1 confirmed that the medical record did not contain a safety plan or intradisiplinary therapeutic treatment plan documentation for the time period of 09/01/23-11/08/23, or any reviews or updates to the plan dated 11/09/23. 3. On 09/18/24 at 11:05 AM, the investigator interviewed a Registered Nurse (RN) (Staff #7). Staff #7 stated that on one day while caring for Patient #1, Patient #1 chased Staff #7 down the hall. Staff #7 feared that they were going to be badly injured. Staff #7 ran out of the unit and held the doors closed. Staff #7 requested to no longer care for Patient #1 because Patient #1 was too dangerous. Staff #7 stated that Patient #1 had also chased a physician into a closet on the unit. 4. On 09/28/24 at 7:20 AM, the investigator interviewed an RN (Staff #4). Staff #4 stated that very early one morning on the night shift, they responded to a scuffling sound coming from the hallway and found Patient #1 with fists raised chasing after a Patient Care Attendant (PCA). Staff #7 stated that he feared Patient #1 would seriously injure the PCA, and he positioned his body between the two. Staff #7 stated they were able to deescalate Patient #1 and help him return to his room. 5. On 09/18/24 at 1:35 PM, the investigator interviewed the Medical Surgical Nurse Manager (Staff #8). Staff #8 stated that Patient #1’s violent outbursts were extremely unpredictable. Staff #8 also stated that the unit had not received the security staff support that they needed to provide a safe environment without the use of restraints. 6. On 09/18/24 at 2:30 PM, the investigator interviewed the Manager of Security (Staff #9). Staff #9 stated that there were not enough security officers available at the time to provide 24/7 security detail for Patient #1. .”

“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: 42597 . Based on document review, medical record review, and interview, the hospital failed to ensure that restraints were imposed only for the immediate physical safety of the patient, staff or others for 1 of 3 records reviewed (Patient #1). Failure to ensure that restraints are only used for immediate physical safety risks physical and psychological injury of the patient and is a violation of patient rights. Findings included: 1. Review of the hospital policy titled, “Restraints/Seclusion,” PolicyStat ID 132977727, approved 03/23, showed that staff should limit the use of restraint to emergencies in which there is an imminent risk of a patient harming themselves, staff or others. 2. On 09/17/24 between 9:00 AM and 11:15 AM, and on 09/20/24 between 9:00 AM and 11:00 AM, the investigator and a Patient Safety Consultant (Staff #1) reviewed Patient #1’s medical record. The review showed the following: a. A Psychiatry note dated 10/13/23 at 1:51 PM documented Patient #1 as lying still in 4 point restraints, alert, speech with normal tone and volume, concrete thought process, and appropriate language. The investigator found no evidence that the provider discontinued the restraint order or attempted to release the patient from restraints. b. On 10/13/23 at 1:59 PM, a provider ordered violent restraints. Documentation showed that Patient #1 remained in restraints until the order was discontinued on 10/14/23 at 8:25 PM c. A Nursing note dated 10/13/24 at 10:10 PM documented “sleeping” as Patient #1’s current response to restraint. The investigator found no evidence showing that that staff attempted to remove the restraints while Patient #1 was sleeping. d. A Nursing note dated 10/14/23 at 3:38 AM documented “sleeping” as Patient #1’s current response to restraint. The investigator found no evidence showing that that staff attempted to remove the restraints while Patient #1 was sleeping. e. A Nursing note dated 10/14/23 at 6:19 AM showed that after an initial outburst at the beginning of the shift, Patient #1 remained calm with no further outbursts. Documentation showed that Patient #1 remained in 4 point violent restraints throughout the shift. The investigator found no evidence showing that that staff attempted to remove the restraints. f. A Psychiatry note dated 10/14/23 at 11:26 AM showed that Patient #1 was restrained, calm, and cooperative. The investigator found no evidence that the provider discontinued the restraint order. g. At the time of review Staff #1 confirmed that restraint for anticipated violence, or restraint of patients who were calm and cooperative, was not a part of the hospital restraint policy. 3. On 09/18/24 at 1:35 PM, the investigator interviewed the Medical Surgical Nurse Manager (Staff #8). Staff #8 stated that Patient #1’s violent outbursts were extremely unpredictable. The hospital has a zero tolerance policy for abuse or assault of caregivers, and restraints were used for Patient #1 to mitigate the risk for assault and injury. .”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(4)(i) The use of restraint or seclusion must be-- (i) in accordance with a written modification to the patient’s plan of care. This Standard is not met as evidenced by: 42597 . Based on document review, medical record review, and interview, the hospital failed to ensure that that a treatment plan was initiated, evaluated, and updated in writing within a timeframe specified by the hospital and that the use of restraint or seclusion was reflected in the individualized patient treatment plan for 1 of 1 patients reviewed (Patient #1). Failure to evaluate and update patient treatment plans risks ineffective interventions. unneccessary use of restraints, and poor outcomes. Findings included: 1. Review of the hospital policy titled, “Restraints/Seclusion,” PolicyStatID 132977727, approved 03/23, showed the following: a. Staff should use critical thinking skills to prevent emergencies that have the potential to lead to restraint use. b. Staff will identify potentially risky or dangerous behaviors early and make a therapeutic care plan to address these concerns. Review of the hospital policy titled, “Individualized Service Plan/Individualized Plan of Care-Inpatient Behavioral Health,” PolicyStatID #9794753, last revised 11/21, showed the following: a. All patients will have an individualized service plan (ISP) initiated within 24 hours of admission; finalized with 72 hours; and reviewed and updated every 7 days thereafter at the multidisciplinary treatment team meeting. b. The initial ISP and all updates will be charted in the patient’s electronic medical record. c. The multidisciplinary team meets daily to review each patient’s progress and updates the ISP and plan of care as needed. d. Every 7 days, the ISP is fully reviewed, updated, and revised to reflect the patient’s changing needs, patient requests, and achievement of goals. 2. On 09/17/24 between 9:00 AM and 11:15 AM, and on 09/20/24 between 9:00 AM and 11:00 AM, the investigator and a Patient Safety Consultant (Staff #1) reviewed the medical records of Patient #1. The review showed the following: a. On 09/01/23, Patient #1 was deemed a danger to others and was involuntarily detained and admitted to the hospital under the Involuntary Treatment Act (the legally enforced hospitalization for mental health treatment) on a single bed certification (admission to a facility that is willing and able to provide the patient with timely and appropriate mental health treatment). b. A scanned document titled, “Therapeutic Planning for (Patient #1),” scanned 11/09/23, no electronic signature, detailed a daily schedule and therapeutic plan for Patient #1. c. At the time of review, Staff #1 confirmed that there was no ISP documented between 09/01/23- 11/09/23, and the ISP scanned 11/09/23 contained no evidence of daily or weekly updates as required by hospital policy. 3. On 09/25/24 between 10:30 AM and 11:00 AM, the investigator interviewed the Director of Quality (Staff #2). Staff #2 stated that patients admitted on single bed certifications should receive care similar to the care provided in the Behavioral Health Unit, but the hospital did not yet have a good system in place to provide behavioral health care to patients receiving care in other units. .”

“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: 42597 . Based on document review, medical record review, and interview, the hospital failed to ensure that restraints were discontinued at the earliest possible time for 3 of 3 records reviewed (Patients #1, #2, and #3). Failure to ensure that patients are released from restraints at the earliest possible time risks physical and psychological injury of the patient and is a violation of patient rights. Findings included: 1. Review of the hospital policy titled, “Restraints/Seclusion,” PolicyStatID 132977727, approved 03/23, showed that staff are responsible for discontinuing restraints at the earliest possible time. 2. On 09/17/24 between 9:00 AM and 11:15 AM, and on 09/20/24 between 9:00 AM and 11:00 AM, the investigator and a Patient Safety Consultant (Staff #1) reviewed the medical records of 3 patients who had been placed in violent restraints. The review showed the following: Patient #1 a. On 09/01/23, Patient #1 was deemed a danger to others and admitted involuntarily for treatment of unpredictable and violent behavior. b. On 10/23/23 at 1:51 PM, Psychiatry documentation showed that Patient #1 was lying still in 4-point restraints, alert, with normal speech tone and volume, using appropriate language, and showing concrete thought processes. c. A physician order, dated 10/13/23 at 1:59 PM, showed an order for restraint, adult violent behavior. d. On 10/13/23 at 10:10 PM, nursing documentation showed the patient’s current behavioral response to restraint as “sleeping.” The investigator found no evidence that the nurse attempted to discontinue the restraints as the patient slept. e. On 10/14/23 at 3:38 AM, documentation on the Nursing 1-hour face-to-face assessment note showed “sleeping” as the current behavioral response to restraint. The investigator found no evidence that the nurse attempted to discontinue the restraints as the patient slept. f. A Nursing note, dated 10/14/23 at 6:19 AM, documented that after an initial outburst at the beginning of the shift, Patient #1 remained calm with no further outbursts and was in 4- point violent restraints throughout the night. g. A Psychiatry note, dated 10/14/23 at 11:26 AM, documented Patient #1 as in restraints and calm and cooperative. The investigator found no evidence that the provider attempted to release Patient #1 from restraints. h. A Nursing note, created on 10/14/23 at 7:41 AM, documented Patient #1’s behavior as: 12:00 PM: patient calm and cooperative with care, watching TV. 1:45 PM: Patient changed to 2-point restraints. 4:41 PM: patient still in 2-point restraint. 1800: patient ate his dinner, patient calm and watching TV. The investigator found no evidence that the nurse attempted to release Patient #1 from restraints. i. On 10/15/23 at 8:25 AM, nursing documentation showed that Patient #2 was calm, cooperative, and pleasant and restraints were discontinued. Patient #2 j. Patient #2 was a 45 year old male admitted for a thigh abscess with sepsis. Patient #2’s medical history included schizoaffective disorder-bipolar type and polysubstance abuse. k. Nursing documentation dated 02/04/24 at 6:03 AM showed that staff heard Patient #2 yelling in his room. Staff responded and found the patient pacing in his room, demanding morphine, and verbally abusing staff. When the patient’s behavior escalated to threats of physical violence, staff called a Code Gray and paged the provider to obtain an order for 4-point violent restraints. l. Physician orders documented restraint for violent behavior from 02/04/24 at 6:06 AM until 02/05/24 at 12:15 PM. m. Restraint flow sheet documentation dated from 02/04/24 at 7:00 AM to 02/05/24 at 9:15 AM showed Patient #2’s behavior as “beginning to rest quietly”, “calming down”, “sleeping”, “sleepy”, or “alert and oriented” every 15 minutes. Restraints were discontinued on 02/05/24 at 9:11 AM. Patient #3 n. On 09/14/24, Patient #3 presented to the Emergency Department for evaluation of violent behaviors and potential psychosis. Patient #3 was severely agitated, and physically and verbally threatening to staff. Patient #3 was placed in 4-point violent restraints, with restraint flowsheet documentation beginning at 2:22 PM. o. The medication administration record (MAR), dated 09/14/24 at 2:13 PM, showed that the patient received 20 mg of ziprasidone (an anti-psychotic medication) administered by intramuscular injection. p. A provider face-to-face assessment dated 09/14/24 at 4:34 PM showed Patient #3’s current behavior response to the restraint as “sleeping,” his mental status as “resting comfortably” after medication and “calm,” and that the patient met criteria for discontinuation of restraints. q. Restraint flow sheet documentation showed that Patient #3 remained in restraints until 5:17 PM. 3. At the time of review, Staff #1 confirmed that hospital restraint policy required discontinuation of restraints at the earliest possible time and that restraint for anticipated violence was not a part of the hospital restraint policy. Staff #1 confirmed that hospital restraint policy did not include restraint of patients who were alert and oriented, sleeping, or sleepy. 4. On 09/18/24 at 1:35 PM, the investigator interviewed the Medical Surgical Nurse Manager (Staff #8). Staff #8 stated that the hospital has a zero-tolerance policy for abuse or assault of caregivers and confirmed that restraints were used for Patient #1 to mitigate the risk for assault and injury. .”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(f)(1) Training intervals. Staff must be trained and able to demonstrate competency in the application of restraints, implementation of seclusion, monitoring, assessment, and providing care for a patient in restraint or seclusion- (i) Before performing any of the actions specified in this paragraph; (ii) As part of orientation; and (iii) Subsequently on a periodic basis consistent with hospital policy. This Standard is not met as evidenced by: 42597 . Based on document review, medical record review, and interview, the hospital failed to ensure that Registered Nurses (RNs) performed effective one hour face-to-face assessments required for the use of restraints for violent behavior for 1 of 3 records reviewed (Patient #1). Failure to perform effective 1 hour face-to-face assessments for patients in violent restraints risks physical and psychological injury and death. Findings included: 1. Document review of the hospital policy titled, “Restraints/Seclusion,” PolicyStatID 132977727, approved 03/23, showed: a. The LIP or “Trained RN” must conduct an in person a face-to-face assessment within 1 hour after a violent or self-destructive restraint application for an adult patient. The “Trained RN” may document a face-to-face re-assessment every 4 hours before calling the LIP to request the renewal order for the violent, self-destructive, or seclusion restraint. b. Prolonged use of restraints may result in active resistance to restraint, which may lead to electrolyte abnormalities or dysrhythmias and may put the patient at further risk for rhabdomyolysis. c. The 1 hour face-to-face assessment includes: i. The patient’s immediate situation. ii. The behavior necessitating restraints. iii. The patient’s reaction to the restraint and current situation. vi. A comprehensive physical and psychological assessment to rule out any underlying issues that could be resolved so that the patient would no longer need restraints. v. The need to continue or remove the restraint. d. RNs should document the 1 hour face-to face assessment by using the note template found in the medical record. 2. On 09/17/24 between 9:00 AM and 11:15 AM, and on 09/20/24 between 9:00 AM and 11:00 AM, the investigator and a Patient Safety Consultant (Staff #1) reviewed Patient #1’s medical record. The review showed the following: a. A nursing note template titled, “Face to Face Assessment of Patient in Restraint or Seclusion or with Violent or Self Destructive Behavior,” dated 10/13/23 at 10:10 PM documented: i. Current behavioral response: “sleeping” ii. Vital signs: Blood Pressure 122/65, Pulse 67, SpO2 96% iii. Psychiatric/social: “still aggressive, verbally abusive, towards staff, yelling and shouting loudly” iv. Behavior necessitating restraint: “verbally abusive towards staff, struggling to get out of bed” v. Level of consciousness: “alert” b. A nursing note template titled, “Face to Face Assessment of Patient in Restraint or Seclusion or with Violent or Self Destructive Behavior,” dated 10/14/23 at 3:38 AM documented: i. Current behavioral response: “sleeping” ii. Vital signs: Blood Pressure 122/65, Pulse 67, SpO2 96% iii. Psychiatric/social: “still aggressive, verbally abusive, towards staff, yelling and shouting loudly” iv. Behavior necessitating restraint: “verbally abusive towards staff, struggling to get out of bed” v. Level of consciousness: “alert”. c. A Nursing note template dated 10/14/23 at 6:19 AM documented that after an initial outburst at the beginning of the shift, the patient remained calm with no further outbursts but was in 4-point violent restraints throughout the night. d. A nursing note template titled, “Face to Face Assessment of Patient in Restraint or Seclusion or with Violent or Self Destructive Behavior,” dated 10/14/23 at 8:07 AM, documented: i. Current behavioral response: “agitated, verbally abuse towards staff, struggling to get out of bed” ii. Vital signs: Blood Pressure 122/65, Pulse 67, SpO2 96% iii. Psychiatric/social: “still aggressive, verbally abusive, towards staff, yelling and shouting loudly” iv. Behavior necessitating restraint: “verbally abusive towards staff, struggling to get out of bed” v. Level of consciousness: “alert” e. A nursing note titled template titled, “Face to Face Assessment of Patient in Restraint or Seclusion or with Violent or Self Destructive Behavior,” dated 10/14/23 at 12:08 PM, documented: i. Current behavioral response: “agitated, verbally abusive towards staff, struggling to get out of bed” ii. Vital signs: Blood Pressure 122/65, Pulse 67, SpO2 96% iii. Psychiatric/social: “still aggressive, verbally abusive towards staff, yelling and shouting loudly” iv. Behavior necessitating restraint as “verbally abusive towards staff, struggling to get out of bed” v. Level of consciousness as “alert”. f. A nursing note template titled, “Face to Face Assessment of Patient in Restraint or Seclusion or with Violent or Self Destructive Behavior,” dated 10/14/23 at 4:35 PM, documented: i. Current behavioral response: “agitated, verbally abusive towards staff, struggling to get out of bed” ii. Vital signs: Blood Pressure 122/65, Pulse 67, SpO2 96% iii. Psychiatric/social: “still aggressive, verbally abusive, towards staff, yelling and shouting loudly” iv. Behavior necessitating restraint: “verbally abusive towards staff, struggling to get out of bed” v. Level of consciousness: “alert” g. A nursing note created on 10/14/23 at 7:41 AM, documented patient behavior throughout the shift as: i. 6:45 AM: patient outburst of yelling, kicking beds, he broke footrest of bed. ii. 9:00 AM: ate 100% of breakfast ... iii. 12:00 PM: ...Patient calm and cooperative with care, watching TV. iv. 1:45 PM: Patient changed to 2 point restraints v. 4:41 PM: Patient still in 2 point restraint. vi. 6:00 PM: Patient ate his dinner 100%, Patient calm and watching TV. h. At the time of review, a Patient Safety Consultant (Staff #1) confirmed that nursing note documentation of Patient #1’s behavior contradicted behavior documented in the 1 hour face-to-face template assessments, and that the 1 hour face-to-face template assessments appeared to be identical and may have been copied and pasted forward for each assessment. 3. On 09/25/24 at 1:10 PM, the investigator interviewed a Registered Nurse (RN)(Staff #3). Staff #3 was not able to articulate the purpose and intent of the 1 hour face-to-face assessment. 4. On 09/18/24 at 11:05 AM, the investigator interviewed a Registered Nurse (RN) (Staff #7). Staff #7 was able not able to articulate the purpose and intent of the 1 hour face-to-face assessment. Staff #7 stated that she hadn’t realized that the face-to-face assessment note templates should not be copied forward from previous assessments. Staff #7 stated that she had received training to do the one hour face-to-face assessment, but could not remember when, and that she didn’t remember repeating the training. 5. On 09/18/24 at 1:35 PM, the investigator interviewed the Medical Surgical Nurse Manager (Staff #8). Staff #8 agreed that it would be very unusual for 1 hour face-to-face assessments to remain exactly the same for 6 assessments, and that face-to-face assessment notes should not be copied forward from previous assessments. Staff #8 stated that restraint documentation completion was reviewed on a daily basis, but the validity and quality of data for restraint use was not something currently tracked. 6. On 09/25/24 at 11:30 AM, the investigator interviewed an Advanced Registered Nurse Practitioner (ARNP)(Staff #11). Staff #11 stated that she developed and implemented both the standard use of restraint training and the additional competency training required for nurses performing 1-hour face-to-face assessments. Staff #11 stated that there was no requirement for nurses to repeat specialized education for performance of 1 hour face-to-face assessments for violent restraints because Staff #11 was not aware of that requirement. Staff #11 stated that that face-to-face assessment template notes should not be copied forward from previous assessments and that the quality of the 1 hour face-to-face assessments was not currently assessed or tracked. .”