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Based on document review, observation and interview, it was determined that the Hospital failed to protect the patient rights of 3 of 4 patients (Pts. #1, #4, & #7) who were confined by restraint or seclusion, by failure to use less restrictive methods prior to use of restraint and seclusion; failure to procure a physician's order for restraints and seclusion; use of restraints as PRN (when needed - at the discretion of the nurse) methods of confinement; and failure to release patients from restraint and seclusion at the earliest time.

As a result, it was determined that the Condition of Participation for Patient Rights, CFR 482.13, was not in compliance.

Findings include:

1. The Hospital failed to ensure that less restrictive measures were attempted prior to the use of restraints or seclusion. See deficiency at A-165.

2. The Hospital failed to ensure that a physician's order for a restraints or seclusion was obtained. See deficiency as A-168.

3. The Hospital failed to ensure that restraints were not used PRN. See deficiency at A-169.

4. The Hospital failed to ensure patients were released from restraint or seclusion at the earliest possible time. See deficiency at A-174.

A. Based on interview and document review, it was determined that for 1 of 10 clinical records reviewed (Pt. #1), the Hospital failed to ensure a patient was involved in their care planning by obtaining a consent for treatment.

Findings include:

1. On 1/15/2020 at 9:00 AM, the Hospital's Consent for Treatment policy was requested, but was not received.

2. On 1/15/2020 at 12:35 PM, an interview was conducted with the Senior Vice President of Quality and Compliance (E #1). E #1 stated that there is no policy for consent, but provided a copy of the "Consent for Treatment and/or Admission" form.

3. The Consent for Treatment and/or Admission form included, "I hereby give consent for medical and/or dental examinations, diagnostic procedures, and treatment... By my signature below, I hereby certify that I have read and understand the forgoing statements and information..."

4. On 1/13/2020, Pt. #1's clinical record was reviewed. Pt. #1 was admitted on 1/7/19, with a complaint of "unresponsive". Pt. #1's ED History and Physical, dated 1/7/19 at 7:29 PM, included, "Brought in by CFD [Chicago Fire Department]... unresponsive since this morning, per kids..."

- A consent for treatment, dated 1/7/19, included "unable to sign" in the place for Pt. #1's signature, and included the initials of one staff member as a witness.

- A physician's note, dated 1/8/19 at 6:27 PM, indicated that Pt. #1 was "lethargic, incoherent speech ... does not follow simple commands ..."

- A psychiatrist's consultation note the next day, on 1/9/19 at 8:27 AM, indicated that Pt. #1 was no longer incapacitated and able to provide a psychiatric history. The note included, " ... Patient seems like a thoughtful person ... well appearing, well groomed ... [oriented to] person, place, time [and] situation ... mood: normal, affect [experience of feeling emotion]: congruent ... thought process: organized ..."

- There was no subsequent signed consent for Pt. #1's admission through discharge on 1/10/19 at 5:31 PM, more than 33 hours after Pt. #1 became alert.

5. On 1/15/2020 at 9:25 AM, a telephone interview was conducted with a Registered Nurse (E #5). E #5 stated that a consent must be signed by the patient or patient's representative. If the patient is unable to sign on admission, the patient should sign the consent when they become alert.

B. Based on interview and document review, it was determined that for 1 of 10 clinical records reviewed (Pt. #1), the Hospital failed to ensure a patient was informed of their treatment by consenting to the psychotropic (mind altering) medications being administered.

Findings include:

1. On 1/15/2020 at 9:00 AM, the Hospital's Consent for Psychotropic Medications policy was requested, but was not received.

2. On 1/15/2020 at 12:35 PM, an interview was conducted the Senior Vice President of Quality and Compliance (E #1). E #1 stated that there is no policy for psychotropic medication consent, but provided the "Psychotropic Medication Attestation" form.

3. The Psychotropic Medication Attestation form included, "I have discussed the following with [Patient's Name]; Benefits/Risks; Side Effects; Alternative Treatment Options; The Right to Refuse..." The form provided space to list the medications, date, and physician's signature.

4. On 1/13/2020, Pt. #1's clinical record was reviewed. Pt. #1 was admitted on 1/7/19, with a complaint of "unresponsive". Pt. #1's ED History and Physical, dated 1/7/19 at 7:29 PM, included, "Brought in by CFD [Chicago Fire Department]... unresponsive since this morning, per kids..."

- Pt. #1's psychiatrist's order, dated 1/9/19 at 11:00 AM, included, "Sertraline [Zoloft - treats depression, anxiety disorder, and panic disorder], 150 mg [milligrams], orally every morning."

- Pt. #1's Medication Administration Record (MAR) included documentation that Pt. #1 received Sertraline, 150 mg on 1/9/19 at 11:38 AM and on 1/10/19 at 9:46 AM. A psychotropic attestation form for Sertraline was not found.

- Pt. #1's physician's order dated 1/9/19 at 7:09 PM, included, "Trazodone [treats depression], 200 mg, orally every day at bedtime."

- Pt. #1's MAR included documentation that Pt. #1 received Trazodone 200 mg on 1/9/19 at 9:00 PM. A psychotropic attestation form for Trazodone was not found.

5. On 1/14/2020 at 1:30 PM, an interview was conducted with a Registered Nurse (E #4). E #4 stated that the patient's family (if the patient is unable to consent) needs to be informed if psychotropic medications are administered to a patient, and the physician has to have a consent signed by the patient or family.

Based on document review and interview, it was determined that for 2 of 4 (Pt. #1, Pt. #4) clinical records reviewed for restraints, the Hospital failed to ensure that the least restrictive measures were utilized prior to placing a patient in seclusion or restraints.

Findings include:

1. The Hospital's policy titled, "Restraint/ Seclusion" (revision date 4/2016), was reviewed on 1/13/2020, and required, "...Non physical interventions are the first choice, unless safety issues demand an immediate physical response... Restraints/seclusion will be used only after less restrictive measures have failed or have been evaluated to be ineffective..."

2. On 1/13/2020, Pt. #1's clinical record was reviewed. Pt. #1 was admitted on 1/7/19, with a complaint of "unresponsive". Pt. #1's ED History and Physical dated 1/7/19 at 7:29 PM, included, "Brought in by CFD [Chicago Fire Department]... unresponsive since this morning, per kids... "

- An ED nursing note (E #5) dated 1/7/19 at 7:27 PM, included, " ...On monitor... IV [intravenous] lines left and right arms, 20 gauge [needle size]... Soft restraint applied ..." There was no documentation to explain why Pt. #1 was in restraints or that other less restrictive interventions had been tried prior to restraint application.

3. On 1/15/2020 at 9:25 AM, a telephone interview was conducted with the Registered Nurse (E #5) who applied Pt. #1's restraints. E #5 stated that soft restraints "are placed on the arms and legs for the patient's safety and to stop them from pulling out their IVs." E #5 stated that she did not remember Pt. #1 or if less restrictive measures had been attempted.

4. The clinical record of Pt #4 was reviewed on 1/13/2020. Pt #4 was admitted on 1/10/2020 with a diagnosis of Schizoaffective Disorder, Bipolar type (serious mental illness). Pt #4's Nursing Progress Note (dated 1/13/2020 at 6:35 AM) included, "Uneventful night...Has been pleasant and cooperative after waking this morning ..." Pt #4's subsequent Nursing Progress Note (dated 1/13/2020 at 11:44 AM) included, "0800 AM: Pt. placed on 1:1 [constant supervision]. Medicated with Ativan (anti-anxiety medication) 2 mg [milligrams] and Haldol (antipsychotic medication) 5 mg and placed in seclusion ..." The clinical record lacked documentation that a less restrictive method was attempted prior to placing the patient in seclusion.

5. On 1/15/2020 at 2:00 PM, an interview was conducted with the Senior Vice President of Patient Care (E #2). E # 2 stated that the least restrictive measures attempted, prior to placing a patient in restraint or seclusion, should be documented in the clinical record under the "24 Hour Restraint Flowsheet" or under the behavioral notes section."

Based on document review and interview, it was determined that for 2 of 4 clinical records reviewed (Pt. #1 & #7) for restraints, the Hospital failed to ensure restraints were applied in accordance with a physician's order.

Findings include:

1. On 1/14/2020, the Hospital's policy titled, "Restraint/ Seclusion Policy," (revised April 2016), was reviewed. The policy required, "IV. Policy... 4. Use of restraint or seclusion must be in accordance with the order of a physician or other licensed independent practitioner who is responsible for the care of the patient and authorized to order restraints or seclusion by Hospital policy (e.g. covering physician)."

2. On 1/13/2020, Pt. #1's clinical record was reviewed. Pt. #1 was admitted on 1/7/19, with a complaint of "unresponsive". Pt. #1's ED History and Physical dated 1/7/19 at 7:29 PM, included, "Brought in by CFD [Chicago Fire Department]... unresponsive since this morning, per kids... "

- An ED nursing note dated 1/7/19 at 7:27 PM, included, "... IV [intravenous] lines left and right arms 20 gauge [needle size]... Soft restraint applied ..." A physician's order for the restraint was not found.


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3. The clinical record for Pt #7 was reviewed on 1/14/2020. Pt # 7 was admitted with the diagnosis of Schizophrenia (serious mental illness). Pt #7's Precaution and Rounding Sheet indicated that Pt. #7 was in the "restraint room" in seclusion on:

- 1/5/2020 from 4:00 PM until 1/6/2020 at 6:45 AM. A nursing progress note dated 1/5/2020 at 11:22 PM, included, "received the pt.[patient] in the room under seclusion..."

- 1/6/2020 from 9:30 AM until 3:45 PM. A nursing note dated 1/6/2020 at 11:23 AM, included, "...pt in seclusion, "should remain in seclusion until violent behavior stops..."

- 1/6/2020 from 8:45 PM until 1/7/2020 at 6:45 AM. A nursing note dated 1/6/2020 at 8:10 PM, included, "...in a seclusion room, for safety, due to aggressive behavior..."

- 1/7/2020 from 9:00 AM until 3:45 PM. A nursing note dated 1/7/2020 at 10:14 AM, included "...pt in therapeutic restraints..."

- The clinical record lacked a physician's order or order renewal for restraints or seclusion for 1/5/2020, 1/6/2020, and 1/7/2020.

4. On 1/15/2020 at 9:25 AM, a telephone interview was conducted with a Registered Nurse (E #5). E #5 stated that she did not remember Pt. #1. E #5 stated that soft restraints "are placed on the arms and legs for the patient's safety and to stop them from pulling out their IVs." E #5 stated that a physician's order is required for soft restraints.

Based on document review and interview, it was determined that for 1 of 4 (Pt #7) clinical records reviewed for restraints, the Hospital failed to ensure that a physician's order was not written as a PRN [on an as needed basis] order.

Findings include:

1. The Hospital's policy titled, "Restraint/ Seclusion" (revision date 4/2016), was reviewed on 1/14/2020, and required, "...Restraints are never ordered as 'PRN' used as a means of coercion, discipline, convenience, or retaliation. Order for restraint or seclusion must never be written as a standing order or on an as needed basis (e.g. PRN order)..."

2. The clinical record for Pt # 7 was reviewed on 1/14/2020. Pt #7 was admitted with the diagnosis of Schizophrenia (serious mental illness). The Physician's Order (dated 1/8/2020) included, "She [Pt #1] was put on seclusion instructed by [MD #3], combative, aggressive behavior towards staff and keep her locked up, release PRN by him [MD #3]."

- Pt #7's Nursing Progress Note (dated 1/6/2020 at 1:24 AM) included, "...seclusion ongoing per Dr. orders..."

3. On 1/15/2020 at approximately 9:30 AM, an interview was conducted with the Senior Vice President of Patient Care (E #2). E #2 stated that an order should be renewed every 2 hours and there should not be a PRN order for restraints.

Based on document review, observation, and interview, it was determined that for 2 of 4 (Pts. #1, & #4) clinical records reviewed for restraints and seclusion, the Hospital failed to ensure that restraints and seclusion were discontinued at the earliest possible time.

Findings include:

1. The Hospital's policy titled, "Restraint/ Seclusion" (revision date 4/2016), was reviewed on 1/13/2020, and required, "...Time- limited orders do not mean that restraint must be applied for the entire length of time for which order was written. Restraint must be discontinued as soon as the individual meets the behavioral criteria for discontinuation... Nursing documentation will include the following: Clinical justification for the length of time..."

2. On 1/13/2020, Pt. #1's clinical record was reviewed. Pt. #1 was admitted on 1/7/19, with a complaint of "unresponsive". Pt. #1's ED History and Physical dated 1/7/19 at 7:29 PM, included, "Brought in by CFD [Chicago Fire Department]... unresponsive since this morning, per kids... "

- Pt. #1's ED nursing note dated 1/7/19 at 7:27 PM, included, "... Soft restraint applied ..." A physician's order for restraint was not found. There was no documentation at what time the restraints were applied or when they were removed. It could not be determined if the restraints were required or removed, at the earliest possible time.

3. On 1/15/2020 at 9:25 AM, a telephone interview was conducted with the Registered Nurse who applied the soft restraints (E #5). E #5 stated that she did not remember Pt. #1, and that soft restraints "are placed on the arms and legs for the patient's safety", and to prevent patients from pulling out their IVs (intravenous access). E #5 did not know when the restraints were removed or if they were removed at the earliest possible time.

4. The clinical record for Pt #4 was reviewed on 1/13/2020. Pt #4 was admitted on 1/10/2020 with the diagnosis of Schizoaffective Disorder, Bipolar type (serious mental illness). Pt #4's Physician's Order (dated 1/13/2020 at 7:45 AM), included, "Place pt [patient] in seclusion for physically hitting/kicking staff. Remove from seclusion when patient is calm for at least 10 minutes."

- Pt #4's Precaution and Rounding Sheet dated 1/13/2020 from 7:00 AM - 9:45 AM, was reviewed. The Precaution and Rounding Sheet indicated that Pt #4 was in seclusion in the "Quiet Room," asleep, on 1/13/2020 from 7:00 AM to 8:30 AM, ate at 8:45 AM, and was sleeping again at 9:00 AM.

- The clinical record lacked documentation indicating the reason why Pt #4 was left in seclusion after Pt. #4 became calm and was sleeping, as the Physician Order indicated.

5. On 1/13/2020, at approximately 10:00 AM, an interview was conducted with Pt. #4's Constant Observer/Sitter (staff assigned to monitor a patient) (E #6), who was present when the rounding sheet was reviewed. E# 6 stated that Pt #4 had been calm since the nurse gave Pt. #4 medication (at 8:00 AM), but was still in seclusion.

6. On 1/13/2020 at approximately 10:10 AM, during an observational tour of the Female Behavioral Health Unit, Pt #4 was observed in the "Quiet Room" (used for seclusion of patients). Pt # 4 was calm and not displaying aggressive behavior, during the tour, greater than 10 minutes.

7. On 1/13/2020 at 10:15 AM, an interview was conducted with the Registered Nurse (E# 7) assigned to Pt #4. E #7 stated that Pt #4 was left in seclusion because Pt. #4 was aggressive. E #7 stated, "I see the benefits of keeping a patient in seclusion so that they don't hurt someone."