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Based on document review, interview, and observation it was determined that for: 2 of 2 (Pt #11 and 12) clinical records reviewed of patients with restraint/seclusion usage; 5 of 5 (Pt #1, 2, 3, 4, and 5) clinical records reviewed for psychotropic medication administration; and 8 of 10 patients (Pts. 2, 3, 4, 6, 7, 8, 9, and 10), on the inpatient psychiatric unit (4 South) reviewed for safety rounds, the Hospital failed to provide and maintain a safe environment for patient care and promote patients' rights of notification and information.

Findings include:

1. The Hospital failed to ensure the patients' family and/or guardian were notified when the patients' rights were restricted. (A 117).

2. The Hospital failed to ensure the patients were informed of information related to psychotropic medications prior to administration. (A 131).

3. The Hospital failed to prevent barricade potential for all patients housed on the 7th floor psychiatric unit. (A 144 A).

4. The Hospital failed to ensure patient safety rounds were conducted every 15 minute as required. (A 144 B).

5. The Hospital failed to ensure the order was complete to include the type of restraint device to be used. (A 165).

6. The Hospital failed to ensure the inclusion of the patient's condition at the time of restraint application. (A 187).

The cumulative effects of these systemic practices resulted in the Hospital's failure to ensure patient safety was maintained. As a result, 42 CFR 482.13 Condition of Participation Patient Rights was not in compliance.


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Based on document review and interview, it was determined that in 2 of 2 (Pt #11 and 12) clinical records reviewed of patients with restraint/seclusion usage, the Hospital failed to ensure the patients' family and/or guardian were notified as required.

Findings include:

1. Hospital policy entitled, "Restraints, Use of and Alternative Measures," (effective date October 9, 2014) required, "Policy: 11. On the Behavioral Health unit, 'Notice Regarding Restricted Rights of Individuals (IL462-2004M) must be completed. The patient should be advised of his right to have any person of his choosing notified. If the patient doe not want anyone notified, this must be documented on the 'Notice Regarding Restricted Rights of Individuals' form..."

2. The clinical record of Pt #11 was reviewed on 12/12/14. Pt #11 was a 58 year old female admitted on 10/6/14 with a diagnosis of schizophrenia. Pt #11's clinical record contained documentation that Pt #11 had been placed in restraints on 10/8/14 at 2:00 AM. The clinical record contained a Notice Regarding Restricted Rights of Individual dated 10/8/14 at 2:00 AM that lacked documentation of who if anyone Pt #11 wanted notified of the restraint usage.

3. The clinical record of Pt #12 was reviewed on 12/12/14. Pt #12 was a 67 year old male admitted on 10/3/14 with a diagnosis of Schizophrenia. Pt #12's clinical record contained documentation that Pt #12 had been placed in seclusion on 10/4/14 at 1:15 AM. The clinical record contained a Notice Regarding Restricted Rights of Individual dated 10/4/14 at 1:15 AM that lacked documentation of who if anyone Pt #12 wanted notified of the seclusion.

4. The Vice President of Patient Care stated during an interview on 12/12/14 at 1:00 PM that the restriction of rights should have been completed.

Based on document review and interview it was determined that in 5 of 5 (Pt #1, 2, 3, 4, and 5) clinical records reviewed for psychotropic medication administration, the Hospital failed to ensure the patients were informed of information related to psychotropic medications prior to administration.

Findings include:

1. Hospital policy entitled, "Informed Consent for Medication Administration," (effective date January 24, 2011) required, "Policy: All patients on inpatient psychiatric units at St. Anthony Hospital who are receiving psychotropic medication will give their informed consent for administration of psychotropic medication....The psychiatrist and patient's signature on the Consent for Medication and Treatment form documents that the patient had give informed consent...Procedure: 1. On the Consent for Medication and Treatment form, the psychiatrist will check off all psychotropic medications administered to the patient..."

2. On 12/11/14 at approximately 1:30 PM the Hospital presented a list of approved psychotropic medications. The list included: Abilify (antipsychotic); Haldol (antipsychotic); Ativan (antianxiety agent); Zyprexa (antipsychotic); Librium (sedative); Thorazine (antipsychotic); Trazodone (antidepressant); and Seroquel (antipsychotic).

3. The clinical record of Pt #1 was reviewed on 12/11/14. Pt #1 was a 61 year old male admitted on 10/16/14 with a diagnosis of agitation. Pt #1's clinical record contained a physician's order dated 10/17/14 that required Librium, Thorazine, Ativan, Haldol, Cogentin (treat side effects of antipsychotics) and Haldol. Pt #1's Medication and Treatment Consent form was undated, did not include the psychotropic medications and did not include Pt #1's signature indicating Pt #1's informed consent for the medications. Clinical documentation indicated the administration of the psychotropic medications.

4. The clinical record of Pt #2 was reviewed on 12/11/14. Pt #2 was a 27 year old male admitted on 12/8/14 with a diagnosis of Agitation. Pt #2's clinical record contained a physician's order dated 12/8/14 that required, Ativan, Cogentin and Haldol. Pt #2's Medication and Treatment Consent form was undated, did not include the psychotropic medications and did not include Pt #2's signature indicating Pt #2's informed consent for the medication administration.

5. The clinical record of Pt #3 was reviewed on 12/11/14. Pt #3 was a 30 year old male admitted on 12/3/14 with a diagnosis of suicide ideation. Pt #3's clinical record contained a physician's order dated 12/3/14 that required Abilify, Ativan, and Trazodone. Pt #3's Medication and Treatment Consent form did not include the psychotropic medications. Clinical documentation indicated the administration of the psychotropic medications.

6. The clinical record of Pt #4 was reviewed on 12/11/14. Pt #4 was a 24 year old male admitted on 12/8/14 with diagnoses of hallucinations and homicidal ideation. Pt #4's clinical record contained a physician's order dated 12/8/14 that required Ativan, Cogentin and Zyprexa. Pt #4's Medication and Treatment Consent form was undated, unsigned by the physician, did not include the psychotropic medications and did not include Pt #4's signature indicating Pt #4's informed consent for the medication administration.

7. The clinical record of Pt #5 was reviewed on 12/11/14. Pt #5 was a 48 year old female admitted on 12/8/14 with a diagnosis of psychoaffective disorder. Pt #5's clinical record contained a physician's order dated 12/8/14 that required Seroquel, Ativan, Cogentin, and Haldol. Pt #5's Medication and Treatment Consent form did not include the list of psychotropic medications.

8. The Manager of the Psychiatric Unit was interviewed on 12/11/14 at 2:15 PM and stated the Medication and Treatment Consent forms should include the medications and the patient's as well as the physician's signatures.

A. Based on document review, observation and interview, it was determined that for 1 of 1 patient on the 4th floor (Pt. #1) who barricaded himself, and 4 of 4 of (Pts. #13, 14, 15, &16) patients on the 7th floor Psychiatric Unit, the Hospital failed to prevent barricade potential for all patients currently housed on the 7th floor psychiatric unit.

Findings include:

1. The clinical record of Pt. #1 was reviewed on 12/11/12. Pt. #1 was a 61 year old male admitted on 10/16/14 with a diagnosis of psychosis. Pt. #1 was documented as having an altercation with his roommate on 10/19/14 at 5:30 PM . The roommate who could not be calmed was taken to the quiet room and medicated, and on return of staff to Pt. #1's room found the door to the room barricaded with the two beds and the night stands. Nursing documentation indicated that attempts to redirect Pt. #1 to remove the barricade were unsuccessful resulting in the Chicago Fire Department opening the door to the patient's room.

2. The Interim Director of Quality was interviewed on 12/12/14 at approximately 1:00 PM. The Director presented and reviewed the corrective action plan in response to the barricade incidence with Pt. #1. The barricade assessment performed after the incident on 11/19/14 concluded that two beds placed end to end with a bedside table or a desk permitted a barricade. The action was to remove all bedside tables and desks from the room until a plan to bolt down the table or desk is completed. However, the action plan did not include prevention of barricade potential for the 7th floor psych unit rooms.

3. An observational tour of the 7th floor Psychiatric Unit was conducted on 12/12/14 at approximately 2:05 PM with the Interim Director of Quality (DQ). The unit with a capacity of 12 patients consisted of 2 single rooms with a bed and a bedside table, and 5 double rooms with 2 beds and 2 bedside tables. The two beds placed end to end and two bedside tables, laid on their side and placed end to end created a barricade that would not allow opening of the door. The 5 double rooms could potentially be barricaded.

4. The census for the 7th floor Psychiatric Unit was reviewed on 12/12/14. There were currently 4 patients on the unit who could potentially barricade the room with the funiture provided in each room:

-Pt. #13, a 56 year old female admitted on 12/6/14 with diagnoses of suicidal ideation, acute anxiety, and acute depression.
-Pt. #14, a 26 year old female admitted on 12/6/14 with diagnoses of acute psychosis and auditory hallucinations.
-Pt. #15, a 47 year old male admitted on 12/8/14, with a diagnosis of acute psychosis.
-Pt. #16, a 72 year old female, admitted on 12/4/14 with a diagnoses of bipolar disorder and aggressive behavior.

5. The above findings were discussed with the Vice President of Patient Services on 12/12/14 at approximately 3:00 PM who stated that patients housed on the 7th floor psychiatric unit are stable and compliant with medication and treatment.


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B. Based on review of Hospital documents and interview, it was determined that for 8 of 10 patients (Pts. 2, 3, 4, 6, 7, 8, 9, and 10), on the inpatient psychiatric unit (4 South) reviewed for safety rounds, the Hospital failed to ensure patient safety rounds were conducted every 15 minute as required.

Findings include:

1. Hospital policy entitled, "Assault Precautions," (effective January 24, 2011) required, "Procedure: 5. A staff member will be assigned to observe the patient's behavior and check on patient's location every 15 minutes...6. The staff member performing the 15-minute observations must document them on the Observation Report Sheet."

2. Hospital policy entitled, "Suicide Precautions with and without Constant Observation (1:1) Observation," (effective date January 24, 2011) required, "Procedure: For either level of suicide precautions: Implementation: For Suicide Precautions with 1:1 supervision: 2. The patient is under constant observation at all times...3. A staff member will be assigned to stay within arm's reach...4. The assigned staff member performing the 1:1 observation must document on the Observation Report Sheet. For Suicide Precautions: 2. A staff member will be assigned to observe the patient's behavior and check on patient's location every 15 minutes...3. The staff member performing the 15-minute observations must document them on the Observation Report Sheet."

3. Hospital policy entitled, "Elopement Precautions," (effective January 24, 2011) required, "Procedure: 7. A staff member will be assigned to observe the patient's behavior and check on patient's location every 15 minutes...8. The staff member performing the 15-minute observations must document them on the Observation Report Sheet."

4. Hospital policy entitled, "Sexual Acting Out Precautions," (effective date February 2005) required, "2.1.7 he patients must be placed on Sexual Acting-Out Precautions and monitored for whereabouts and activity every 15 minutes. 2.1.8 The assigned staff member performing the 15 minutes checks must document the check on the Observation Report Sheet."

5. On 12/11/14 the "Observation Precautions Sheet(s)" for 12/10/14 for the 4 South Unit were reviewed. These forms were incomplete. The forms lacked documentation from 6:00 PM - 6:45 PM for the following patients:

-Pt#2, a 27 year old male admitted on 12/8/14 with a diagnosis of agitation, was on suicide and assault precautions;

-Pt#3, a 30 year old male admitted on 12/3/14 with a diagnosis of suicide ideation, was on suicide and assault precautions;

-Pt#4, a 24 year old male admitted on 12/8/14 with diagnoses of hallucinations and homicidal ideation's, was on suicide precaution, assault and elopement precautions;

-Pt#6, a 55 year old male admitted on 12/3/14 with a diagnosis of bipolar disorder, was on assault, seizure precautions, and fall precautions;

-Pt#7, a 25 year old male admitted on 12/5/14 with a diagnosis of schizoaffective disorder, was on close observation, elopement and sexually acting out precautions;

-Pt#8, a 49 year old male admitted on 12/2/14 with a diagnosis of acute psychosis, was on close observation and suicide precautions;

-Pt#9, a 24 year old male admitted on 12/7/14 with diagnoses of depression and suicidal ideation, was on suicide and assault precautions and;

-Pt#10, a 50 year old male admitted on 12/4/14 with a diagnosis of bipolar disorder, was on assault precautions.

6. On 12/11/14 at approximately 11:45 AM, the Behavioral Health Manager was interviewed and stated the forms should have been completed every 15 minutes.

7. On 12/11/14 at approximately 1:45 PM, the Mental Health Worker (MHW) (E#1) assigned to perform the 15 minute checks was interviewed and stated on 12/10/14, he was the MHW assigned to to do the safety rounds. E#1 stated that during his lunch break (6:00 PM) the 15 minute checks were assigned to another MHW who was a registry technician. E#1 stated that he did not notice after returning from break that the safety round sheet had not been completed during 6:00 PM-6:45 PM.

Based on document review and interview, it was determined that in 1 of 2 (Pt #11) clinical records reviewed of patients with restraint usage, the Hospital failed to ensure the order was complete to include the type of restraint device to be used.

Findings include:

1. Hospital policy entitled, "Restraints, Use of and Alternative Measures," (effective date October 9, 2014) required, "Policy: 5. Only restraint device approved for use at Saint Anthony Hospital may be used..."

2. The clinical record of Pt #11 was reviewed on 12/12/14. Pt #11 was a 58 year old female admitted on 10/6/14 with a diagnosis of schizophrenia. Pt #11's clinical record contained Restraint or Seclusion Order Forms dated 10/8/14 at 2:00 AM and 10/8/14 at 9:30 PM that lack an order for the type of restraint device to be used.

3. The Vice President of Patient Care stated during an interview on 12/12/14 at 1:00 PM that the type of restraints used should have been documented on the order sheet.

Based on document review and interview, it was determined that for 1 of 2 (Pt #11) clinical records reviewed of patients that utilized restraint devices, the Hospital failed to ensure the inclusion of the patient's condition at the time of restraint application.

Findings include:

1. Hospital policy entitled, "Restraints, Use of and Alternative Measures," (effective date October 9, 2014) required, "Behavioral Care Restraints: 3. Documentation with the plan of care for the patient placed in restraints or seclusion must include the following:..c. The patient's condition or symptom(s) that warranted the use..."

2. The clinical record of Pt #11 was reviewed on 12/12/14. Pt #11 was a 58 year old female admitted on 10/6/14 with a diagnosis of schizophrenia. Pt #11's clinical record contained Restraint or Seclusion Order Forms dated 10/7/14 at 8:15 AM and 10/8/14 at 2:00 AM. The form required documentation of "Restraint as per the following:..." The orders lacked documentation of the patient's behavioral condition that indicated dangerous behavior to him/herself/others.

3. The Vice President of Patient Care stated during an interview on 12/12/14 at 1:00 PM that the patient's condition was not documented on the restraint order.