HospitalInspections.org

Based on observation, interview, and record review, the Governing Body of the hospital failed to ensure the provision of quality of care to its patients when the new "Use of Restraint or Seclusion" policies and procedures were implemented without adequate staff training. The hospital Governing Body failed to ensure that each patient had the right to be free from all forms of physical restraints.

The Governing Body failed to ensure that the hospital staff documented an assessment prior to the application of physical restraints which had the potential to result in the application of restraints without an appropriate assessment and therefore without need for the restraint. (A0154)

The Governing Body failed to ensure the hospital staff honored patients' rights to be free from restraints when staff raised four side rails up without following appropriate process which had resulted in restricting their freedom to exit the bed. Consequently, these patients' rights to be free from restraints were violated. (A0161)

The Governing Body failed to ensure its staff tried less restrictive physical restraints which had placed these patients at risk for a decline in physical condition. (A0165)

The Governing Body failed to ensure a care plan was developed to include the use of side rails as an intervention to prevent falls which could result in the unnecessary use of physical restraints in non-emergency situations. (A0166)

The hospital failed to ensure a physician's order was obtained prior to initiating restraints which had the potential to use restraints unnecessarily. (A0168)

The Governing Body failed to ensure all nursing staff completed annual restraint training, which had the potential to adversely affect patient rights. (A0196)

The Governing Body failed to ensure staff were aware of the current policy and procedure for restraint application which could result in inconsistent applications of restraints by the hospital staff. (A0199)

The Governing Body failed to ensure plan of care was developed which could result in the needs of the patient not being met. (A0396)

The Governing Body failed to insure the contracted licensed nurses had received the hospital's restraint policy and procedure training, which had the potential of causing harm to patients. (A0398)

The Governing Body failed to ensure physicians' telephone verbal restraint orders were authenticated by the physicians within 48 hours, which had the potential to place patients safety at risk. (A0457)

The cumulative effects of these systemic failures resulted in the failure of the Governing Body's legal responsibility for the daily operation of the hospital in the provision of quality and safe patient care as mandated in the condition of coverage.

Based on observation, interview, and record review, the hospital failed to protect its patients' basic rights to be free from any form of restraint when side rails were imposed without following the processes established by the hospital. This failure resulted in inappropriate and unnecessary use of physical restraints in the hospital.

The hospital failed to document an assessment prior to the application of physical restraints which had the potential to result in the application of restraints without an appropriate assessment and therefore without need for the restraint. (A0154)

The hospital staff violated patients' rights to be free from restraints when staff raised four side rails up without following appropriate processes had resulted in restricting their freedom to exit the bed. Consequently, these patients' rights to be free from restraints were violated. (A0161)

The hospital staff failed to attempt less restrictive physical restraints which had placed these patients at risk for decline in physical condition. (A0165)

The hospital failed to ensure a care plan was developed to include use of side rails as an intervention to prevent falls which could result in unnecessary physical restraints. (A0166)

The hospital failed to ensure a physician's order was obtained prior to initiating restraints which had the potential to use restraints unnecessarily. (A0168)

The cumulative effects of these systemic failures resulted in the failure of the hospital leadership to honor patients' rights when the side rails were used without following the hospital's policy and procedure on "Use of Restraint or Seclusion."

Based on observation, interview and record review, the hospital staff failed to document an assessment prior to the application of physical restraints for seven of 19 sampled patients (2, 3, 4, 6, 7, 8, and 9). This had the potential to result in the application of restraints without an appropriate assessment and therefore without need for the restraint.

Findings:

1. During an observation with Charge Nurse (CN) 1 on the California Department of Correction (CDC) floor on May 3, 2010 at 1:55 PM, Patient 2 was lying in bed with all four side rails up. Patient 2 was observed to have his right ankle shackled to the right lower side rail. CN 1 stated, Patient 2 does have the capability to get up out of bed and should not have all four side rails up while in bed. During a subsequent interview with CN 1, she stated, "I don't know why he has side rails up."

The electronic medical record (EMR) for Patient 2 was reviewed with CN 1 on May 3, 2010 at 3:15 PM. There was no documentation an assessment was done prior to placing all four side rails up nor did it contain continuing assessment for the continued need of all four side rails up.

During an interview with Registered Nurse (RN) 1, on May 4, 2010 at 9:20 AM, she indicated prior to initiating a restraint, the nurse must initiate the "restraint documentation". The restraint documentation included such items as the type of restraint used and the medical or behavioral symptom necessitating the restraint. The EMR for Patient 2 did not contain this restraint documentation.



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2. On May 3, 2010 at 1:30 PM, during an initial tour, Patient 3 was observed in bed with all four side rails up. Patient 3 was able to make his needs known but required assistance in bed for mobility due to his contracture.

On May 4, 2010 at 10:25 AM, CN 3 was interviewed. She stated the reason for Patient 3 to have all four side rails up was for fall prevention. CN 3 stated Patient 3 had been found to place his legs out of bed when his lower side rails were down. The staff was afraid he would fall out of bed. She was not certain his leg movement was related to involuntary jerking or voluntary movement. When requested to review the side rail assessment and care plan, CN 3 was unable to provide any documentation.

3. On May 3, 2010 at 2:30 PM, Patient 4 was observed in bed with all four side rails up. He was able to move all extremities in bed and was alert with periods of confusion.

On May 4, 2010 at 9:20 AM, during a concurrent interview, CN 3 stated Patient 4 had all four side rails up to prevent him from falling out of bed. However, she was unable to provide documentation that Patient 4 was assessed or care planned for the need of side rails. She stated Patient 4, at 2:30 AM, was pulling his intravenous tubes and knocking down the IV poles. Nursing staff informed his physician and initiated wrist restraints to both wrists as ordered. Later, a Respiratory Therapist was able to adjust his tracheotomy tube and improved his breathing. At 3:30 AM, a clinical note read, "Patient presently on bilateral wrist restraints. He is no longer agitated and is calm. CN 3 stated, "I went to (Patient 4's) room earlier and saw a care partner (Certified Nursing Assistant 4) feed him breakfast. He was calm, cooperative, and appropriate. At 10:20 AM, CNA (Certified Nursing Assistant) 4 was interviewed. When asked if she had released his wrist restraints while she was helping him to eat breakfast, she said, "His both arms were tied down." She added that Patient 4 was calm and cooperative this morning but he continued to be tied down by both wrist restraints and continued to all four side rails up. At 10 AM, when questioned if a lesser restrictive restraint was attempted prior to use of wrist restraints, CN 3 could not provide any documentation. She stated, "It was not there."

On May 5, 2010 at 10 AM, the Chief Nursing Officer was informed of the above findings. She stated, "I don't think side rails are restraints. I was thinking the mechanical part of restraints." She stated the hospital quality did not consider the side rail use would be a quality issue for the same reason.



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4. During an observation of the telemetry floor with the Telemetry Director (TD) on May 3, 2010 at 2:30 PM, seven of the 44 patients had four side rails in the up position.

The clinical records for four of the seven patients (6, 7, 8, and 9) were reviewed with the TD on May 3, 2010 at 2:45 PM. None of the four patient's records had an assessment for the use of side rails. She stated the nursing staff should be documenting the use of four side rails in their assessments. The TD stated Patient 6 was oriented and able to get up by himself to ambulate, therefore he should not of had all four of his side rails in the up position.

During an interview with the TD and Patient 6 on May 3, 2010 at 3:30 PM, Patient 6 stated, "I don't like all the side rails up because I can't go to the bathroom by myself. I wish the nurses would stop putting them up."

The hospital policy and procedure titled, "Use of Restraint or Seclusion," effective date March 12, 2010, under the definition subheading read in part, "...The use of side rails to prevent the patient from exiting the bed would be considered a restraint." Under the policy subheading, it read in part, "Each episode of restraint...should contain at least the following documentation in the patient's medical record...Individual patient assessments and reassessments."

Based on observation, interview, and record review, the hospital staff raised all four side rails up for seven of 19 (2, 3, 4, 6, 7, 8, and 9) patients resulting in restricting their freedom to exit the bed. Consequently, these patients' rights to be free from restraints were violated.

Findings:

1. On May 3, 2010 at 1:30 PM, during an initial tour, Patient 3 was observed in bed with all four side rails up. Patient 3 was able to make his needs known but required assistance in bed with mobility due to his contracture.

On May 4, 2010 at 10:25 AM, CN (Charge Nurse) 3 was interviewed. She stated the reason for Patient 3 to have all four side rails up to prevent him from falling out of bed. CN 3 stated Patient 3 had been found to place his legs out of bed when his lower side rails were down. She further explained that he might fall if his legs were out of bed and use of side rails can prevent his legs coming out of bed. CN 3 was unable to locate any documentation that Patient 3 was ever assessed for the need to use side rails since his admission which was two months ago. CN 3 stated, "We should use pillows or something else to position him (in bed)."

2. On May 3, 2010 at 2:30 PM, Patient 4 was observed in bed with all four side rails up. He was able to move all extremities in bed and was alert with periods of confusion.

On May 4, 2010 at 9:20 AM, during a concurrent interview, CN 3 stated Patient 4 had all four side rails up to prevent him from falling out of bed. CN 3 was unable to provide documentation that Patient 4 was assessed for the need of all four side rails.

On May 5, 2010 at 8:50 AM, during an interview, the Nursing Quality Specialist stated at this hospital, the side rails were used for fall prevention and were not treated as a form of restraint.



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3. During an observation of the hospital's three intensive care units (ICU) with CN 4 on May 3, 2010 at 1:30 PM, all 24 patients had all four side rails in the up position. She stated that was the practice in the ICU for all the patients. When asked if the use of all four side rails required an assessment, physician's order and a care plan, she stated no.

During an interview with the Director of Critical Care (DCC) on May 3, 2010 at 1:40 PM, she stated the use of four side rails was part of the fall risk protocol for the hospital.

During an interview with the Risk Manager on May 3, 2010 at 2 PM, she stated the hospital does not have a fall risk protocol.

The facility policy and procedure titled, "Use of Restraint or Seclusion Policy and Procedure" with an effective date of March 12, 2010 read in part, "...obtaining a physician's...order prior to initiating each episode of restraint...use....The use of restraint...must be documented in the patient's plan of care..."

4. During an observation of the telemetry floor with the Telemetry Director (TD) on May 3, 2010 at 2:30 PM, seven of the 44 patients had four side rails in the up position.

The clinical records for four of the seven patients (6, 7, 8, and 9) were reviewed with the TD on May 3, 2010 at 2:45 PM. None of the four patient's records had an assessment or a carnelian for the use of side rails. She stated the nursing staff should be documenting the use of four side rails in their assessments and care plan for their use. The TD stated Patient 6 was oriented and able to get up by himself to ambulate, therefore he should not of had all four of his side rails in the up position.

During an interview with the TD and Patient 6 on May 3, 2010 at 3:30 PM, Patient 6 stated, "I don't like all the side rails up because I can't go to the bathroom by myself. I wish the nurses would stop putting them up."



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5. During an observation with CN 1 on the California Department of Correction (CDC) floor on May 3, 2010 at 1:55 PM, Patient 2 was lying in bed with all four side rails up. Patient 2 was observed to have his right ankle shackled to the right lower side rail. CN 1 stated, Patient 2 does have the capability to get up out of bed and should not have all four side rails up while in bed. During a subsequent interview with CN 1, she stated, "I don't know why he has the side rails up."

The electronic medical record (EMR) for Patient 2 was reviewed with CN 1 on May 3, 2010 at 3:15 PM. There was no documentation an assessment was done prior to placing all four side rails up nor did it contain continuing assessment for the continued need of all four side rails up.

During an interview with Registered Nurse (RN) 1, on May 4, 2010 at 9:20 AM, she indicated prior to initiating a restraint, the nurse must initiate the "restraint documentation". The restraint documentation included such items as the type of restraint used and the medical or behavioral symptom necessitating the restraint. The EMR for Patient 2 did not contain this restraint documentation.

The hospital policy and procedure titled, "Use of Restraint or Seclusion", effective date March 12, 2010, under the definition subheading read in part, "...The use of side rails to prevent the patient from exiting the bed would be considered a restraint." Under the policy subheading, it read in part, "Each episode of restraint...should contain at least the following documentation in the patient's medical record...Individual patient assessments and reassessments..." Included in this policy and procedure was "...side rails are frequently not used as a method to prevent the patient from falling out of bed, but instead, used to restrict the patient's freedom to exit the bed."

Based on observation, interview, and record review, the hospital staff failed to attempt appropriate alternatives to four of 19 (2, 3, 4, and 18) patients prior to use of more restricted physical restraints which had placed these patients at risk for a decline in physical condition.

Findings:

1. On May 3, 2010 at 1:30 PM, during an initial tour, observed Patient 3 in bed with all four side rails up. Patient 3 was able to make his needs known but required assistance in bed mobility due to his contracture.

On May 4, 2010 at 10:25 AM, Charge Nurse (CN) 3 was interviewed. She stated the reason for Patient 3 to have all four side rails up was for fall prevention. CN 3 stated Patient 3 had been found to place his legs out of bed when his lower side rails were down. She further explained that he may fall if his legs were out of bed. Use of side rails can prevent his legs coming out of bed. CN 3 was unable to locate any comprehensive assessment addressing his need side rails since his admission. CN 3 stated, "The side rails were used to prevent him from falling out of bed," and added, "We should use pillows or something else to position him (in bed)."

2. On May 3, 2010 at 2:30 PM, Patient 4 was observed in bed with all four side rails up. He was able to move all extremities in bed and was alert with periods of confusion.

On May 4, 2010 at 9:20 AM, during a concurrent interview, CN 3 stated Patient 4 had all four side rails up to prevent him from falling out of bed. She stated Patient 4, at 2:30 AM, was pulling his intravenous tubes and knocking down the IV poles. Nursing staff informed his physician and initiated wrist restraints to both wrists. CN 3 further explained that shortly after the episode, a Respiratory Therapist was able to improve his breathing and oxygenation. At 3:30 AM, a nurse's clinical note read, "Patient presently on bilateral wrist restraints. He is no longer agitated and is calm." CN 3 stated, "I went to (Patient 4's) room earlier and saw a care partner (Certified Nursing Attendant 4)) feed him breakfast. He was calm, cooperative, and appropriate." At 10:20 AM, CNA 4 was interviewed. CNA 4 stated that while she was helping him to eat breakfast, "His both hands were tied down." She added that Patient 4 was calm and cooperative during breakfast. She released his wrist restraints when he was asked to reposition in bed. He was able to help. CNA 4 confirmed that Patient 4 continued to use both wrist restraints and four side rails. At 10 AM, when questioned if a lesser restrictive restraint was attempted prior to the use of wrist restraints, CN 3 stated, "No. It was not there."

On May 5, 2010 at 8:50 AM, the Nursing Quality Specialist was informed of the above findings. She was unable to provide any documentation that a less restricted restraint was tried prior to using wrist restraints to tie down both of Patient 4's wrists.



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3. During an observation of the medical floor with CN 3 on May 4, 2010 at 10:15 AM, Patient 18 was in bed with all four side rails in the up position, soft tie restraints on both of her wrists were tied to the bed frame, and Certified Nursing Assistant (CNA) 1 was assigned as a sitter for her and her roommate.

During an interview with CNA 1 on May 4, 2010 at 10:35 AM, she stated she was afraid Patient 18 might pull out her urinary catheter or intravenous line. When asked if she had difficulty seeing Patient 18 when she was giving her roommate care, she stated, "No, I keep the curtain open enough that I can see her. Her roommate doesn't require much care. She just needs to be watched."

During an interview with Registered Nurse 5 on May 4, 2010 at 10:40, she stated, "My intent is to try to take them (soft ties) off sometime today, but I am afraid she might pull her catheter (urinary) or her IV(intravenous) line, even with the sitter in there." When asked if she had assessed Patient 18 for the continued need of the soft ties or side rails, she stated, "No, not yet." When asked what time her shift had started that morning, she stated at 7 AM.



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4. During an observation with CN 1 on the California Department of Correction (CDC) floor on May 3, 2010 at 1:55 PM, Patient 2 was lying in bed with all four side rails up. Patient 2 was observed to have his right ankle shackled to the right lower side rail. CN 1 stated, Patient 2 does have the capability to get up out of bed and should not have all four side rails up while in bed. During a subsequent interview with CN 1, she stated, "I don't know why he has side rails up."

The electronic medical record (EMR) for Patient 2 was reviewed with CN 1 on May 3, 2010 at 3:15 PM. There was no documentation an assessment was done prior to placing all four side rails up nor did it contain continuing assessment for the continued need of all four side rails up. There was no documentation of the need for the the four side rails up or any less restrictive alternatives tried prior to placing all four side rails up.

The hospital policy and procedure titled, "Use of Restraint or Seclusion", effective date March 12, 2010, under the definition subheading read in part, "...The use of side rails to prevent the patient from exiting the bed would be considered a restraint." Under the policy subheading it read in part, "The use of restraint or seclusion is limited to those situations for which there is adequate and appropriate clinical justification. The use of restraint or seclusion occurs only after alternatives to such use have been considered and/or attempted as appropriate..." And "Depending on the patient's needs and situational factors, the use of restraint or seclusion may require either periodic (e.g., every 15 minutes, every 2 hours, etc.) or continual (i.e., moment to moment) monitoring and assessment." During further review of this policy and procedure, under the subtitle, "ALTERNATIVES TO THE USE OF RESTRAINT & SECLUSION" on page 4, it read: "The use of restraint or seclusion is based on the assessed needs of the patient. Restraint or seclusion may only be used when less restrictive interventions have been determined to be ineffective to protect the patient ..."

Based on observation, interview, and record review, the hospital failed to ensure a care plan was developed for seven of 19 patients (2, 3, 4, 6, 7, 8, and 9) to include the use of side rails as an intervention to prevent falls which could result in the unnecessary use of physical restraints in non-emergency situations.

Findings:

1. During an observation with Charge Nurse (CN) 1 on the California Department of Correction (CDC) floor on May 3, 2010 at 1:55 PM, Patient 2 was lying in bed with four side rails up. Patient 2 did have his right ankle shackled to the right lower side rail. CN 1 stated, Patient 2 does have the capability to get up out of bed and should not have all four side rails up while in bed. During a subsequent interview with CN 1, she stated, "I don't know why he has side rails up."

The electronic medical record (EMR) for Patient 2 was reviewed with CN 1 on May 3, 2010 at 3:15 PM. There was no evidence an individualized care plan was developed for the use of the four side rails which prevented the patient from exiting the bed.



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2. On May 3, 2010 at 1:30 PM, during an initial tour, Patient 3 was observed in bed with all four side rails up. Patient 3 was oriented and able to make his needs known but required assistance in bed mobility due to his contracture.

On May 4, 2010 at 10:25 AM, during a concurrent review, CN 3 stated the reason for Patient 3 to have all four side rails up was for fall prevention because he would put his legs off his bed when lower rails were down. She proceeded to refer to Patient 3's plan of care for falls and was unable to find "side rail use" was listed as one of the interventions.

3. On May 3, 2010 at 2:30 PM, Patient 4 was observed in bed with all four side rails up. He was able to move all extremities in bed and was alert with periods of confusion.

On May 4, 2010 at 9:20 AM, during a concurrent interview, CN 3 stated Patient 4 had all four side rails up to prevent him from falling out of bed. She was unable to find use of side rails as one of the interventions that was designed to prevent his fall on his plan of care for falls.



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3. During an observation of the telemetry floor with the Telemetry Director (TD) on May 3, 2010 at 2:30 PM, seven of the 44 patients had four side rails in the up position.

The clinical records for four of the seven patients (6, 7, 8, and 9) were reviewed with the TD on May 3, 2010 at 2:45 PM. None of the four patient's records had a care plan for the use of side rails. She stated the nursing staff should be documenting the use of four side rails in their assessments and creating an carnelian.

The hospital policy and procedure titled, "Use of Restraint or Seclusion", effective date March 12, 2010 read in part under the policy subheading, "The use of restraint or seclusion... must be documented in the patient's plan of care...The use of a restraint or seclusion intervention should be reflected in the patient's plan of care or treatment plan based on an assessment and evaluation of the patient. The plan of care...should be reviewed and updated within 24 hours following the initiation of restraint or seclusion."

Based on observation, interview and record review, the hospital failed to ensure a physician's order was obtained prior to initiating the restraint for three of 19 of sampled patients (2, 3, and 4).

Findings:

1. During an observation with Charge Nurse (CN) 1 on the California Department of Correction (CDC) floor on May 3, 2010 at 1:55 PM, Patient 2 was lying in bed with four side rails up. Patient 2 did have his right ankle shackled to the right lower side rail. CN 1 stated, Patient 2 does have the capability to get up out of bed and should not have all four side rails up while in bed. During a subsequent interview with CN 1, she stated, "I don't know why he has side rails up."

The clinical record for Patient 2 was reviewed with CN 1 on May 3, 2010 at 3:15 PM. There was no physician's order noted in the clinical record and this was acknowledged by CN 1.



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2. On May 3, 2010 at 1:30 PM, during an initial tour, Patient 3 was observed in bed with all four side rails up. Patient 3 was able to make his needs known but required assistance in bed mobility due to his contracture.

On May 4, 2010 at 10:25 AM, CN 3 was interviewed. She stated the reason for Patient 3 to have all four side rails up was for fall prevention. CN 3 stated Patient 3 had been found to place his legs out of bed when his lower side rails were down. She further explained that he may fall if his legs were out of bed. Use of side rails can prevent his legs coming out of bed. There was no physician's order for use four side rails in his records.

3. On May 3, 2010 at 2:30 PM, Patient 4 was observed in bed with all four side rails up. He was able to move all extremities in bed and was alert with periods of confusion.

On May 4, 2010 at 9:20 AM, during a concurrent interview, CN 3 stated Patient 4 had all four side rails up to prevent him from falling out of bed. CN 3 stated there was no physician's order for use of four side rails in his records.

On May 5, 2010 at 8:50 AM, during an interview, the Nursing Quality Specialist was informed of the above findings. She stated the side rails were used to prevent patients from falling out of bed, and not considered as physical restraints. Consequently, the process of restraint use in the hospital was not established.

The hospital policy and procedure titled, "Use of Restraint or Seclusion" with an effective date of March 12, 2010, read in part, "This policy requires that a physician or other licensed independent practitioner...responsible for the care of the patient order restraint or seclusion prior to the application of restraint or seclusion."

Based on interview and record review, the hospital failed to ensure five nursing staff members {Charge Nurse (CN) 4, Registered Nurse (RN) 6, Registered Nurse (RN) 7, Certified Nursing Assistant (CNA) 2, Certified Nursing Assistant (CNA) 3} completed annual restraint training, which had the potential to adversely affect patient rights.

Findings:

1. The restraint training for three nurses (CN 4, RN 6, RN 7) were reviewed on May 5, 2010 at 10:30 AM. The Transcript Report for CN 4 indicated she had received restraint training on October 16, 2008 and February 1, 2010. The Transcript Report for RN 6 indicated she had received restraint training on November 17, 2008 and March 1, 2010. The training for both were approximately 15 1/2 months apart. The Transcript Report for RN 7 indicated he received restraint training on December 1, 2008. No other completion dates were found in his report. The Assignment Completion Report dated May 4, 2010 indicates RN 7 has not completed restraint training since December 1, 2008. The last training for RN 7 was approximately 18 months ago.

During an interview with the Director of Human Resources (DHR) on May 5, 2010 at 10:45 AM, she stated if staff does not complete the required training, they are given a verbal warning, then a written warning, and then terminated by their managers. During this time, the employee file for RN 7 was reviewed with her. She confirmed there was not evidence of corrective action concerning RN 7's non-compliance with restraint training in his file.



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2. The restraint training was reviewed for two certified nursing assistants (CNA 2 and CNA 3) on May 5, 2010 at 10:30 AM. The latest documented evidence of restraint training for CNA 2 was November 10, 2008. The latest documented evidence of restraint training for CNA 3 was September 22, 2008. No other evidence was provided that CNA 2 or CNA 3 had more recent training in the hospital's restraint policy and procedure.

During an interview with the DHR on May 5, 2010 at 10:55 AM, she indicated all hospital employees should receive training in restraints upon hire and annual thereafter. She was unable to provide any further evidence CNA 2 or CNA 3 received annual training in the hospital's restraint policy and procedure.

The hospital policy and procedure titled "Restraint and Seclusion" dated March 12, 2010 read, "Ongoing Evaluation of Competency: Annual evaluation of competency by successful completion of Restraint Management Learning Module and Exam."

Based on interview and record review, the hospital failed to ensure staff were aware of the current policy and procedure for restraint application which could result in inconsistent applications of restraints by the hospital staff.

Findings:

During an interview with the Nursing Quality Specialist (NQS) and the Chief Nursing Officer (CNO), on May 3, 2010 at 4:15 PM, they indicated there were only "format changes" to the new restraint policy and procedure and the effective date for the new restraint policy and procedure was March 12, 2010. According to the NQS, she indicated they combined three old restraint policies and procedures into one restraint policy and procedure. The old restraint policy was divided into an administrative policy, medical restraint policy and a behavioral restraint policy. According to the CNO, there were "no content changes" and therefore there was not an organized hospital wide education for hospital staff. "The three policies were just put into one policy."

The hospital policy and procedure titled, "Use of Restraint or Seclusion Policy and Procedure", with an effective date of March 12, 2010 was reviewed and compared with the old policy and procedures for restraint application on May 4, 2010 at 3:10 PM. The old policies and procedures titled, "Restraint Management Policy", "Restraint (MEDICAL) Procedure", and "Restraint (BEHAVIORAL ) Procedure" were reviewed. When reviewing the latest policy and procedure with the old policy and procedures related to restraint management there were notable changes. The latest policy and procedure defines physical restraints more extensively. The policy and procedure defines what is not considered a restraint i.e. IV (Intravenous) armboards, bodily positioning devices, strollers, safety belts, high chair lap belts. It also addresses more extensively what is considered a restraint i.e. side rails, chemical restraints and it addresses seclusion. The old policies and procedures do not mention the use of side rails as a restraint nor does it address the use of chemical restraint or seclusion. The list of alternatives to the use of restraint was significantly reduced in comparison to the old restraint policy and procedures.

During an interview with the NQS on May 4, 2010 at 3:55 PM, she acknowledged the differences between the old and new restraint policy and procedure. She indicated, now that she was aware of the changes to the hospital's restraint policy and procedure, a hospital wide education program will be started. She stated, "We weren't going to educate..." but now that the differences in the policies are noted we will educate.

Based on observation, interview, and record review, the hospital's performance improvement activities failed to analyze the possible cause of a death that could be related to the use of side rails in the hospital. Consequently, the leadership did not implement preventive measures to decrease the potential risks for side rail entrapment.

The hospital's performance improvement activities failed to document an assessment prior to the application of physical restraints which had the potential to result in the application of restraints without an appropriate assessment and therefore without need for the restraint. (A0154)

The hospital's performance improvement activities staff violated patients' rights to be free from restraints when staff raised four side rails up without following appropriate process had resulted in restricting their freedom to exit the bed. Consequently, these patients' rights to be free from restraints were violated. (A0161)

The hospital's performance improvement activities staff failed to try less restrictive physical restraints which had placed these patients at risk for a decline in physical condition. (A0165)

The hospital's performance improvement activities failed to ensure a care plan was developed to include use of side rails as an intervention to prevent falls which could result in the use of unnecessary physical restraints. (A0166)

The Governing Body failed to ensure its staff tried less restrictive physical restraints which had placed these patients at risk for a decline in physical condition. (A0165)

The hospital's performance improvement activities failed to ensure physicians' telephone verbal restraint orders were authenticated by the physicians within 48 hours, which had the potential to place its patients' safety at risk. (A0263)

The hospital's performance improvement activities failed to ensure plan of care was developed for its patients which could result in the needs of the patients not being met. (A0396)

The hospital's performance improvement activities failed to insure the contracted licensed nurses had received the hospital's restraint policy and procedure training, which had the potential of causing harm to patients. (A0398)

The cumulative effects of these systemic failures resulted in the failure of the hospital's performance improvement activities to recognize the use of side rails in its daily operation could have posed a risk for patients to be entrapped by side rails.

Based on interview and record review, the hospital failed to conduct an analysis of the possible causes of an adverse patient event for one of 19 patients (19) which had prevented the hospital to evaluate the practice of using side rails for fall prevention in the hospital. Such failure had the potential to cause side rail entrapment.

Findings:

On March 17, 2010, the hospital reported to the Department a possible side rail related death occurred on March 16, 2010. During the investigation on March 17, 2010, the hospital records revealed that Patient 19, who was under incarceration at the time and had all four side rails up, was found on the floor, on the left side of bed with both ankles shackled to the lower side rails. Patient 19 died an hour after the fall incident.

On May 3, 2010 at 10:30 AM, during an interview, the hospital Risk Manager was asked whether the hospital did a root-and-cause analysis after the adverse event, she stated that a team was put together that included the Director of the unit, the representatives from the correctional facility, and staff nurses. The team concluded that the root cause was "fail to monitor the inmates." She stated the team did not look into the side rails issue nor recognize the practice of side rail use in the hospital.

On May 4, 2010 at 3:45 PM, the hospital's policy on "Performance Improvement Plan" was reviewed. Under "PERFORMANCE IMPROVEMENT PRIORITIES," subtitle 1.d. read; "Analysis of data regarding the process elements and outcome measures contained in our internal database and information obtained from external comparative data bases to reduce the risk of adverse patient outcomes."

Based on observation, interview, and record review, the hospital's nursing service failed to ensure the delivery of individualized care was directed by the plan of care developed, and the provision of care was administered by competent and trained staff.

The hospital nursing staff failed to try less restrictive physical restraints first which had placed these patients at risk for a decline in physical condition. (A0165)

The hospital nursing staff failed to ensure a care plan was developed to include the use of side rails as an intervention to prevent falls which could result in the unnecessary use of physical restraints. (A0166)

The hospital nursing staff failed to ensure a physician's order was obtained prior to initiating restraints in non-emergency situations. (A0168)

The hospital Nursing Services failed to ensure all nursing staff completed annual restraint training, which had the potential to adversely affect patient rights. (A0196)

The hospital Nursing Services failed to ensure staff were aware of the current policy and procedure for restraint application which could result in inconsistent applications of restraints by the hospital nursing staff. (A0199)

The Governing Body failed to ensure plan of care was developed which could result in the needs of the patient needs not being met. (A0396)

The Governing Body failed to insure the contracted licensed nurses had received the hospital's restraint policy and procedure training, which had the potential of causing harm to patients. (A0398)

The hospital staff failed to ensure physicians' telephone verbal orders were authenticated by the physicians within 48 hours, which had the potential for risks to patient safety. (A0457)

The cumulative effects of these systemic failures in nursing practices resulted in the failure of the hospital to monitor the provision of quality and safe patient care as mandated in the condition of coverage.

Based on observation, interview and record review, the hospital failed to ensure a care plan was developed for seven of 19 sampled patients (2, 3, 4, 6, 7, 8, 9) which could result in patient safety and patient rights being violated due to an undeveloped, individualized plan of care.

Findings:

1. During an observation with Charge Nurse (CN) 1 on the California Department of Correction (CDC) floor on May 3, 2010 at 1:55 PM, Patient 2 was lying in bed with four side rails up. Patient 2 did have his right ankle shackled to the right lower side rail. CN 1 stated, Patient 2 does have the capability to get up out of bed and should not have all four side rails up while in bed. During a subsequent interview with CN 1, she stated, "I don't know why he has side rails up."

The electronic medical record (EMR) for Patient 2 was reviewed with CN 1 on May 3, 2010 at 3:15 PM. There was no evidence an individualized care plan was developed for the use of the four side rails which prevented the patient from exiting the bed.



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2. On May 3, 2010 at 1:30 PM, during an initial tour, Patient 3 was observed in bed with all four side rails up. Patient 3 was able to make his needs known but required assistance in bed mobility due to his contracture.

On May 4, 2010 at 10:25 AM, CN 3 was interviewed. She stated the reason for Patient 3 to have all four side rails up to prevent him from falling out of bed. CN 3 stated Patient 3 had been found to place his legs out of bed when his lower side rails were down. She further explained that he might fall if his legs were out of bed and use of side rails could prevent his legs coming out of bed. CN 3 was unable to provide a plan of care to include the use of side rails as an intervention for fall prevention.

3. On May 3, 2010 at 2:30 PM, Patient 4 was observed in bed with all four side rails up. He was able to move all extremities in bed and was alert with periods of confusion.

On May 4, 2010 at 9:20 AM, during a concurrent interview, CN 3 stated Patient 4 had all four side rails up to prevent him from falling out of bed. CN 3 was unable to provide a plan of care to include the use of side rails as an intervention for fall prevention.



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4. During an observation of the telemetry floor with the Telemetry Director (TD) on May 3, 2010 at 2:30 PM, seven of the 44 patients had four side rails in the up position.

The clinical records for four of the seven patients (6, 7, 8, 9) were reviewed with the TD on May 3, 2010 at 2:45 PM. None of the four patient's records had a care plan for the use of side rails. She stated the nursing staff should be documenting the use of four side rails in their assessments and creating a carnelian.

The hospital policy and procedure titled, "Use of Restraint or Seclusion", effective date March 12, 2010 read in part under the policy subheading, "The use of restraint or seclusion... must be documented in the patient's plan of care...The use of a restraint or seclusion intervention should be reflected in the patient's plan of care or treatment plan based on an assessment and evaluation of the patient. The plan of care...should be reviewed and updated within 24 hours following the initiation of restraint or seclusion."

Based on interview and record review, the hospital failed to insure that three of the hospital's fourteen contracted licensed nurses (Registered Nurse 2, 3, and 4) had received the hospital's restraint policy and procedure training, which had the potential of causing harm to patients.

Findings:

The training records for three of 14 contracted Registered Nurses (RN) 2, 3, and 4 were reviewed on May 5, 2010 at 10:30 AM. The records indicated these three contracted RN's had not received the hospital's training on the restraint policy and procedures.

During an interview with th Nursing Staff Coordinator (NSC) on May 5, 2010 at 10:45 AM, she stated the hospital did not train the contracted licensed nurse on the hospital's restraint policy and procedure. She stated the hospital contracts through several different agencies and those agencies were responsible for training the nurses on restraints.

The hospital's restraint policy and procedure was compared with both agencies' restraint policies. Both the agency's policies and procedures did not indicated side rails as a physical restraint.

Based on interview and record review, the hospital failed to ensure physicians' telephone verbal restraint orders were authenticated by the physicians within 48 hours for two out of 19 sampled patients (2 and 10) which had the potential to place patients' safety at risk.

Findings:

1. The clinical record for Patient 2 was reviewed on May 4, 2010 at 11:30 AM. The document tiled "Restraints Order Renewals" for April 29, 30, 2010 and May 1, 20010 did not contain a physicians's signature within 48 hours after a telephone verbal order was taken in order to continue Patient 2's restraints. This was verified by Charge Nurse (CN) 4. During this time, CN 4 stated the physicians should be signing the restraint orders everyday after they assess the patient.

2. The clinical record for Patient 10 was reviewed on May 4, 2010 at 10:40 AM. The document titled "Restraints Order Renewals" for April 22, 23, 24, 2010 and May 1, 2, 2010 did not contain a physician's signature within 48 hours after a telephone verbal order were taken in order to continue Patent 10's restraints. This was verified by CN 4.