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Based on review of Hospital policy, clinical record review and staff interview,it was determined that the Hospital failed to ensure: 1 of 10 patients were informed of their rights regarding treatment (A 116A); 2 of 10 patients were informed that restraints may be utilized to prevent harm to themselves and/or others (A 116B); 4 of 7 restraint orders for the management of violent or self-destructive behavior were renewed every 4 hours for adults (A 171); 1 of 10 documentation for the time restraints were removed (A 174A); 1 of 7 patients' restraints were removed at the earliest possible time (A 174B); 5 of 10 patients in restraints were monitored according to policy (A 175); and 2 of 7 patients placed in restraints were seen face to face by a medical professional trained in restraint assessment within 1 hour after the initiation of the restraint (A 178).

The cumulative effect of these systemic problems resulted in the Hospital's inability to ensure the provision of patient's rights.

A. Based on review of the Hospital consent form, clinical record review, and staff interview it was determined that for 1 of 10 clinical records reviewed (Pt. #2), the Hospital failed to ensure patients were informed of their rights regarding treatment.

Findings include:

1. On 10/4/10 at 11:00 AM, the Hospital's "Universal Consent" form was reviewed. It included information regarding treatment and was to be signed by the patient.

2. On 10/4/10 at 10:30 AM, the clinical record of Pt. #2 was reviewed. Pt. #2 was a 31 year old female, treated in the Emergency Department on 9/20/10, with a diagnosis of Altered Mental Status. The record failed to include a signed universal consent form.

3. This finding was confirmed by the Vice President of Patient Care Services during an interview on 10/5/10 at 11:30 AM.

B. Based on review of Hospital policy, clinical record review, and staff interview it was determined that for 2 of 10 clinical records reviewed (Pts. #8 & 10), the Hospital failed to ensure patients were informed that restraints may be utilized to prevent harm to themselves and/or others.

Findings include:

1. On 10/4/10 at 2:45 PM, the Hospital policy titled: "Protective Devices" was reviewed. The policy required: "Patient and Family Education... The patient and / or family member will be informed that medical interventions will be needed to prevent harm to themselves or others, which may include restraints..."

2. On 10/4/10 at 2:00 PM, the clinical record of Pt. #8 was reviewed. Pt. #8 was a 41 year old male, treated in the Emergency Department (ED) on 9/9/10, with a diagnosis of Acute Alcohol Intoxication. ED nursing notes on 9/9/10 at 6:35 PM, indicated that "4 point restraints" had been applied in the ambulance and remained on until Pt. #8 was discharged, on 9/10/10 at 8:40 AM. The record lacked documentation that Pt. #8 was informed that restraints would be used to prevent harm to self and others.

3. On 10/4/10 at 2:30 PM, the clinical record of Pt. #10 was reviewed. Pt. #10 was a 34 year old male, treated in the ED on 9/25/10 with a diagnosis of Suicidal Ideation. ED nursing notes on 9/25/10 at 3:27 PM, indicated that "4-point restraints" were observed at the shift change. Restraints were discontinued on 9/25/10 at 5:54 PM. The record lacked documentation that Pt. #10 was informed that restraints would be used to prevent harm to self or others.

4. These findings were confirmed by the Vice President of Patient Care Services during an interview on 10/5/10 at 9:00 AM.

A. Based on review of Hospital policy, clinical record review, and staff interview it was determined that for 4 of 7 clinical records reviewed (Pt. #5, 6, 7, & 8) for patients restrained for behavioral reasons, the Hospital failed to ensure restraint orders for the management of violent or self-destructive behavior was renewed every 4 hours.

Findings include:

1. On 10/4/10 at 2:45 PM, the Hospital policy titled: "Protective Devices" was reviewed. The policy required: "Use of Restraints for Behavioral Purpose...2. Each written order for a behavioral restraint is limited to 4 hours for adults... The original order may only be renewed in accordance with these limits for up to a total of 24 hours..."

2. On 10/4/10 at 1:15 PM, the clinical record of Pt. #5 was reviewed. Pt. #5 was a 46 year old male, treated in the Emergency Department (ED) on 8/28/10, with a diagnosis of Altered Mental Status. ED nursing notes on 8/28/10 at 11:30 PM, indicated that restraints were applied for behavioral reasons and were discontinued on 8/29/10 at 9:13 AM. The record lacked documentation of renewal restraint orders.

3. On 10/4/10 at 1:30 PM, the clinical record of Pt. #6 was reviewed. Pt. #6 was a 45 year old male, treated in the ED on 8/31/10, with a diagnosis of Alcohol Intoxication. ED nursing notes on 8/31/10 at 1:22 PM, indicated that restraints were applied for behavioral reasons and were discontinued on 9/1/10 at 2:00 AM. The record lacked documentation of renewal restraint orders.

4. On 10/4/10 at 1:45 PM, the clinical record of Pt. #7 was reviewed. Pt. #7 was a 49 year old male, treated in the ED on 9/4/10, with a diagnosis of Suicidal Ideation. ED nursing notes on 9/4/10 at 3:04 PM, included: "...remains in restraints". The record lacked documentation to indicate that Pt. #7 was released from restraints before transfer. Renewal restraint orders from 9/4/10 at 11:00 AM to 9/5/10 at 3:00 AM were not signed by a physician.

5. On 10/4/10 at 2:00 PM, the clinical record of Pt. #8 was reviewed. Pt. #8 was a 41 year old male, treated in the ED on 9/9/10, with a diagnosis of Acute Alcohol Intoxication. ED nursing notes on 9/9/10 at 6:35 PM, indicated that "4 point restraints" had been applied in the ambulance and remained on Pt. #8 until discharged on 9/10/10 at 8:40 AM. The record lacked documentation of renewal restraint orders.

6. These findings were confirmed by the Vice President of Patient Care Services during an interview on 10/5/10 at 9:00 AM.

A. Based on review of Hospital policy, clinical record review and staff interview, it was determined that in 1 of 10 (Pt #1) clinical records reviewed, the Hospital failed to document the time that restraint devices were removed.

Findings include:

1. Hospital policy entitled, "Protective Devices," reviewed on survey date 10/4/10 at 10:00 AM required, "Documentation Summary: Documentation will be on the Restraint Flow Record, the 24 hour flow sheet, the Restraint Order Forms...Documentation will include the following..Discontinuation."

2. The clinical record of Pt #1 was reviewed on survey date 10/4/10 at 9:00 AM. Pt #1 was a 35 year old male who presented to the Hospital ' s Emergency Department (ED) on 7/22/10 at 6:18 AM, in the custody of the Chicago Police Department (CPD), with a chief complaint of Forearm Laceration. A physician order dated 7/22/10 at 6:30 AM, required the application of four (4) point locked restraints in response to Pt #1 ' s aggressive, threatening behavior that included kicking, spitting and biting. Documentation indicated that Pt #1 was placed in locked leather restraints at 6:30 AM, however, documentation failed to indicate the time Pt. #1 was released from the restraint devices.

3. The finding was confirmed with the Vice President of Patient Services during an interview on 10/5/10 at 9:00 AM.


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B. Based on review of Hospital policy, clinical record review, and staff interview it was determined that for 1 of 7 clinical records reviewed (Pt. #7) for patients restrained for behavioral reasons, the Hospital failed to ensure restraints were removed at the earliest possible time.

Findings include:

1. On 10/4/10 at 2:45 PM, the Hospital policy titled: "Protective Devices" was reviewed. The policy required: "Application of restraints for protective purposes and behavioral management... Restraints must be ended at the earliest possible time... Early Release... If the behavior that necessitated restraint subsides, patients may be released before the end of the period specified in the order... Restraints are to be ended at the earliest possible time."

2. On 10/4/10 at 1:45 PM, the clinical record of Pt. #7 was reviewed. Pt. #7 was a 49 year old male, treated in the Emergency Department (ED) on 9/4/10, with a diagnosis of Suicidal Ideation. ED nursing notes on 9/4/10 at 3:04 PM, included: "...remains in restraints". The record lacked documentation that Pt. #7 was released from restraints before transfer. Behavioral Restraint Care Sheets indicated that Pt. #7 was asleep and no longer a behavioral threat on 9/5/10 from 6:15 AM until 5:30 PM. The record lacked documentation of the need for continued restraint.

3. These findings were confirmed by the Vice President of Patient Care Services during an interview on 10/5/10 at 9:00 AM.

A. Based on review of Hospital policy, clinical record review, and staff interview it was determined that for 5 of 10 clinical records reviewed (Pts. #3, 4, 5, 7, and 8), the Hospital failed to ensure patients in restraints were monitored according to policy.

Findings include:

1. On 10/4/10 at 2:45 PM, the Hospital policy titled: "Protective Devices" was reviewed. The policy required: "Use of Restraints for Behavioral Purpose...The patient will be reassessed every 15 minutes and documentation will be done on the 24 hour restraint flow sheet..."

2. On 10/4/10 at 11:00 AM, the clinical record of Pt. #3 was reviewed. Pt. #3 was a 55 year old male, treated in the Emergency Department (ED) on 8/23/10, with diagnoses of Dyspnea and Tracheostomy Evaluation. ED nursing notes on 8/23/10 at 12:55 PM, include: "per MD soft protective restraints applied." However, an assessment/ reassessment monitoring flow-sheet was not found in the record.

3. On 10/4/10 at 1:00 PM, the clinical record of Pt. #4 was reviewed. Pt. #4 was a 44 year old female, treated in the Emergency Department (ED) on 8/22/10, with diagnoses of Abdominal Pain and Alcoholic Gastritis. A physician's order dated 8/23/10 at 3:45 AM included, "locked restraint" and Nursing notes on 8/23/10 at 7:30 AM, indicated the restraints were discontinued. However, the record lacked documentation of reassessment every 15 minutes on 8/23/10 from 4:00 PM until 7:30 PM.

4. On 10/4/10 at 1:15 PM, the clinical record of Pt. #5 was reviewed. Pt. #5 was a 46 year old male, treated in the Emergency Department (ED) on 8/28/10, with a diagnosis of Altered Mental Status. ED nursing notes on 8/28/10 at 11:30 PM, indicated that restraints were applied for behavioral reasons and were discontinued on 8/29/10 at 9:13 AM. However, the record lacked documentation of reassessment every 15 minutes on 8/29/10 from 6:00 AM until 9:00 AM.

5. On 10/4/10 at 1:45 PM, the clinical record of Pt. #7 was reviewed. Pt. #7 was a 49 year old male, treated in the Emergency Department (ED) on 9/4/10, with a diagnosis of Suicidal Ideation. ED nursing notes on 9/4/10 at 3:04 PM, included: "...remains in restraints". The record lacked documentation of complete reassessment every 15 minutes on 9/4/10 from 11:00 AM to 1:00 PM and on 9/5/10 from 4:45 PM to 6:00 PM.

7. On 10/4/10 at 2:00 PM, the clinical record of Pt. #8 was reviewed. Pt. #8 was a 41 year old male, treated in the Emergency Department (ED) on 9/9/10, with a diagnosis of Acute Alcohol Intoxication. ED nursing notes on 9/9/10 at 6:35 PM, indicated that "4 point restraints" had been applied in the ambulance and remained on Pt. #8 until discharged on 9/10/10 at 8:40 AM. The record failed to include documentation of assessment every 15 minutes.

8. These findings were confirmed by the Vice President of Patient Care Services during an interview on 10/5/10 at 9:00 AM.

A. Based on review of Hospital policy, clinical record review, and staff interview it was determined that for 2 of 7 clinical records reviewed (Pt. #5 & 6) for patients restrained for behavioral reasons, the Hospital failed to ensure each patient placed in restraints was seen face to face by a medical professional trained in restraint assessment within 1 hour after the initiation of the restraint.

Findings include:

1. On 10/4/10 at 2:45 PM, the Hospital policy titled: "Protective Devices" was reviewed. The policy required: "Use of Restraints for Behavioral Purpose... There must be a 1 hour face to face evaluation done after the application of the restraint for behavioral purposes and a consult done with the attending physician."

2. On 10/4/10 at 1:15 PM, the clinical record of Pt. #5 was reviewed. Pt. #5 was a 46 year old male, treated in the Emergency Department (ED) on 8/28/10, with a diagnosis of Altered Mental Status. ED nursing notes on 8/28/10 at 11:30 PM, indicated that restraints were applied for behavioral reasons and were discontinued on 8/29/10 at 9:13 AM. There was no documentation that a Physician examined Pt. #5 within 1 hour of restraint application.

3. On 10/4/10 at 1:30 PM, the clinical record of Pt. #6 was reviewed. Pt. #6 was a 45 year old male, treated in the Emergency Department (ED) on 8/31/10, with a diagnosis of Alcohol Intoxication. ED nursing notes on 8/31/10 at 1:22 PM, indicated that restraints were applied for behavioral reasons and were discontinued on 9/1/10 at 2:00 AM. There was no documentation that a Physician examined Pt. #6 within 1 hour of restraint application.

4. These findings were confirmed by the Vice President of Patient Care Services during an interview on 10/5/10 at 9:00 AM.

A. Based on review of the Hospital's Performance Improvement Plan, Emergency Department (ED) Quality Improvement Reports, and staff interview, it was determined that the Hospital failed to ensure that in 1 of 1 patient service (ED) areas, data collected was utilized to improve patient care and safety.

Findings include:

1. The Hospital's Performance Plan for FY 2011 was reviewed on 10/4/10 at 1:30 PM. The Plan required, "Policy: Holy Cross Hospital embodies a committee by our community. The Performance Improvement Plan is designed to objectively and systematically monitor and evaluate the quality and effectiveness of care/services and to identify and purse opportunities to improve."

2. The ED's Quality Improvement Reports for 12/9 to 2/10 and 5/10 to 9/10 were reviewed on 10/4/10 at 1:00 PM. The reports indicated the following actions would be followed: "Next steps: Corrective Counseling with RN's and MD's on orders." "Focused
education with nursing and physician on correct type of restraints." However, no documentation was found that the plan was implemented.

3. The Director of Quality was interviewed on 10/5/10 at 8:45 AM. The Director stated that the Hospital does not have any documentation related to focused education and/or corrective counseling in regards to the ED's Quality Reports for restraint usage.

4 The findings were confirmed with the Director of Quality during an interview on 10/5/10 at 11:00 AM.

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A. Based on review of the Hospital's Performance Improvement Plan, Emergency Department (ED) Quality Improvement Reports, ED staff meeting minutes, and staff interview. It was determined that for 1 of 1 Patient Care Service area (ED), the Hospital failed to ensure restraint monitoring activities included measure, analyze, and tract, and preventative action were implemented to improve patient care restraint issues.

Findings include:

1. The Hospital's Performance Plan was reviewed on survey date 10/4/10 at 1:30 PM. The Plan required, "Program Activities: Holy Cross Hospital staff will measure, analyze and tract indicators including adverse patient events, processes of care and operations. Priorities will be focused on high risk, high volume, or problem prone areas. Performance Improvement teams will be implemented as necessary." The Quality Indicators for the Hospital's Emergency Department included, "Restraint usage with 100% documentation compliance and as problem prone high risk."

2. The ED's Restraint Management Quality Improvement Reports for 12/09 to 2/10 and 5/10 to 9/10 were reviewed on survey date 10/4/10 at 1:00 PM. The Quality Improvement Reports included that the following indicators would be tracked for appropriate restraint usage: "Correct Type, Alternatives, Education, Correct ND orders, Assessed 2 hours, Assessed 15 minutes, order renewal, and discontinuation information." During the two quarters of data collection, the results indicated that the ED failed to meet the goal of 100%.

3. The documented "Method for Improvement" required, "Focused education with nursing and physician on correct type of restraint."

4. The Hospital's ED Staff Meeting Minutes for July 19 and 23, 2010 were reviewed on survey date 10/5/10 at 9:45 AM. The minutes indicated that, restraint type, patient education, discontinuation of restraints, and renewal orders were discussed. The sign-in list for the meetings indicated that 12 of 25 ED staff nurses attended, less than 50 % of the staff nurses and 0% of the physicians attended the staff meetings.

5. The Vice President of Patient Care Services stated during an interview on survey date 10/5/10 at approximately 10:00 AM that there is no documentation that the remainder of ED nurses were in serviced regarding restraints.

6. The Director of Quality was interviewed on survey date 10/5/10 at 8:45 AM. The Director stated that the Hospital does not have any documentation related to focused education in regards to the ED's Quality Reports for restraint usage.

7. The findings were confirmed with the Director of Quality during an interview on survey date 10/5/10 at 11:00 AM

B. Based on review of Hospital policy, clinical record review, request for occurrence reports, and staff interview, it was determined that for 1 of 1 patient (Pt. #4) who was found on the floor in the Emergency Department, the Hospital failed to ensure occurrence reports were written when potential injuries occurred in order to identify opportunities for improvement.

Findings include:

1. Facility policy titled: "Occurrence Reports" was reviewed on 10/5/10 at 11:20 AM. The policy required: "A. Occurrence reports should be written on any occurrence involving the hospital... Adversely affects or threatens to affect the comfort, health or life of a patient... fall."

2. On 10/4/10 at 1:00 PM, the clinical record of Pt. #4 was reviewed. Pt. #4 was a 44 year old female, treated in the Emergency Department (ED) on 8/22/10, with diagnoses of Abdominal Pain and Alcoholic Gastritis. ED nursing notes on 8/22/10 at 9:25 PM, included: "Patient [Pt. #4] found lying on the floor..."

3. On 10/4/10 at 3:00 PM, the occurrence report related to Pt. #4's incident was requested from the Director of Quality. On 10/5/10 at 8:30 AM, the Director of Quality stated that an occurrence report was not done. The finding was confirmed with the Director of Quality at this time.

A. Based on review of the Hospital's Emergency Department (ED) Quality Improvement Reports for 12/09, 1/10, 2/10, 5/10, 7/10, and 8/10, and staff interview, it was determined that the Hospital failed to ensure improvement in the appropriate use of restraints.

Findings include:

1. The Hospital's Performance Improvement Plan was reviewed on survey date 10/4/10 at approximately 1:30 PM. The Plan required, "...IV. Organization:...Hospital Leadership: Hospital directors, managers, and supervisors are responsible for - 1. Undertaking education concerning the approaches and methods of performance improvement. 2. Assuring that staff is trained in assessing and improving the processes that contribute to improved outcomes...Joint Quality Improvement Committee: The Joint Quality Improvement Committee (JQIC) is a multidisciplinary Committee organized to monitor and improve quality. Its purpose s to assure that the Medical Staff and Hospital are fulfilling their responsibility to maintain quality care..."

2. The Hospital's Emergency Department (ED) Quality Improvement Reports for 12/09, 1/10, 2/10, 5/10, 7/10, and 8/10 were reviewed on survey date 10/4/10 at approximately 1:00 PM. The Dec/Jan/Feb report documented an 86% regarding the discontinuation of restraints and the May/July/Aug report indicated a drop to 66 % documentation.

The Dec/Jan/Feb report documented a 91% fifteen minute assessment documentation and the May/July/Aug report indicated a drop to 82 % documentation in 15 minutes assessment. No action was identified addressing the decline in restraint practice.

The Dec/Jan/Feb report documented a 98% correct physician order and the
May/July/Aug report indicated a drop to 89 % documentation in correct physician order

3. These findings were confirmed by the Director of Quality during an interview on 10/5/10 at 11:00 AM.