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Based on staff interview and review of medical records, hospital policies, patient rights information, and complaint/grievance documentation, it was determined the hospital failed to ensure patient rights were protected and promoted. This interfered with the ability of patients to exercise their rights related to grievances, restraints, and visitation. Findings include:

1. Refer to A-0118 as it relates to the failure of the hospital to ensure implementation of a process for the prompt resolution of patient grievances.

2. Refer to A-0119 as it relates to the failure of the hospital's governing body to ensure a comprehensive, effective grievance process was developed, implemented and monitored.

3. Refer to A-0121 as it relates to the failure of the hospital to establish a clearly explained procedure for the submission of a patient's written or verbal grievance to the hospital.

4. Refer to A-122 as it relates to the failure of the hospital to communicate a time frame for responses to grievances that was consistent with hospital policy and to provide responses within specified time frames.

5. Refer to A-0123 as it relates to the failure of the hospital to ensure patients were provided with written responses to documented grievances.

6. Refer to A-0154 as it relates to the failure of the hospital to ensure behavioral restraints were used in accordance with hospital policy and that restraints were discontinued at the earliest possible time.

7. Refer to A-0168 as it relates to the failure of the hospital to ensure physicians were contacted immediately after emergency application of restraints.

8. Refer to A-0171 as it relates to the failure of the hospital to ensure orders for behavioral restraints did not exceed 4 hours.

9. Refer to A-0188 as it relates to the failure of the hospital to ensure the rationale for the continued use of restraints was documented.

10. Refer to A-0207 as it relates to the failure of the hospital to define qualifications for restraint trainers to ensure appropriate education, training, and experience associated with the use of restraints.

11. Refer to A-0214 as it relates to the failure of the hospital to ensure tracking of a death that occurred within 24 hours of a patient being removed from 2-point, soft wrist restraints.

12. Refer to A-0216 as it relates to the failure of the hospital to ensure patients (or support persons, where appropriate) were clearly informed of the right to receive visitors of choice, including, but not limited to, a spouse, a domestic partner (including a same-sex domestic partner), another family member, or a friend, and the right to withdraw or deny such consent at any time.

The cumulative effects of these negative systemic practices impeded the ability of the hospital to ensure patient rights were protected and promoted.

Based on staff interview and review of medical records, meeting minutes, and grievance documentation, it was determined the hospital failed to ensure implementation of a process for the prompt resolution of patient grievances for 2 of 10 patients (#1 and #4) whose medical records were reviewed and 8 of 10 grievances identified and documented by the hospital for 2014 and 2015. This resulted in incomplete resolution of grievances. Findings include:

1. The hospital's "Clinical Process Scoreboard" for 2014, attached to Governing Body meeting minutes, documented 9 grievances for 2014.

All documentation related to the grievances referenced on the 2014 "Clinical Process Scoreboard" was requested for review. Documentation provided by the Regional Director of Quality & Risk Management included 2 grievances from 2014, one of which included a letter of response from the hospital. There was no information provided related to the other 7 grievances referenced on the "Clinical Process Scoreboard" for 2014. The information provided was not sufficient to demonstrate prompt resolution of patient grievances.

Additionally, documentation provided by the Regional Director of Quality & Risk Management included one grievance from 2015. However, a "Clinical Process Scoreboard" for 2015 was not provided.

During an interview on 5/27/15 at 9:00 AM, the Regional Director of Quality & Risk Management stated she could not find any other documentation related to complaints and grievances. She stated the compliance officer who had been responsible for complaints and grievances vacated the position recently and no one was serving in the position at the time of the survey.

The hospital's documentation did not demonstrate that an effective process for prompt resolution of patient grievances had been established.

2. Patient #1 and Patient #4's medical records were reviewed. The records documented grievances expressed by the patients' family members. There was no evidence the grievances were included in the grievance process and assured prompt resolution.

a. Patient #1 was a 65 year old female who was admitted to the hospital on 6/13/14 related to respiratory failure.

A CM note, dated 6/20/14, stated the patient's daughter arrived and voiced multiple concerns. It stated nursing concerns were forwarded to the DNO. The specific concerns were not included in the CM note.

The CM was interviewed on 5/27/15 at 10:10 AM. When asked what she remembered about the concerns, she stated a daughter was concerned that her mother was getting too much anxiety medication. When asked if the concerns were documented, she stated they were not, they were dealt with verbally.

A physician's progress note, dated 6/20/14, stated he was stopped by the DNO and the CM regarding a phone call (by Patient #1's family) to another hospital in Boise regarding a potential transfer of Patient #1. There was an hour and a half of discussion with the patient alone and then with the patient and family members to discuss the potential transfer and the issues that the patient and her family had been having since her admission. The specific concerns were not included in the physician's progress note.

There was no documentation describing the grievances discussed, including prompt resolution of the grievances. The Regional Director of Quality and Risk Management confirmed the lack of documentation during an interview on 5/27/15 at 11:00 AM.



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b. Patient #4's medical record was reviewed. He was a 69 year old male who was admitted to the hospital on 2/11/14 related to a diagnosis of acute respiratory failure.

A CM note, dated 2/17/14, stated the CM met with the family of Patient #4. The note stated the family had concerns related to patient care. It also stated concerns were discussed with the Director of Quality and the DNO.

The CM was interviewed on 5/27/15, beginning at approximately 10:05 AM. When asked if concerns were documented and addressed as a grievance, she stated they were not, but she felt they were dealt with verbally at the time.

A CM note, dated 2/18/15, stated Patient #4 was transferred to another facility at the request of the family.

A physician's progress note, dated 2/17/14, stated Patient #4's son was at the bedside and upset about a sequence of events that resulted in the transfer of Patient #4 to the critical care unit. The note stated the son felt care for his father had not been good. The note further stated the physician spent 30 minutes discussing Patient #4's situation with the son.

There was no documentation describing the grievances discussed, including prompt resolution of the grievances. The Regional Director of Quality and Risk Management confirmed the lack of documentation during an interview on 5/27/15 at 11:00 AM.

Based on staff interview, and review of medical records, hospital policies, grievance documentation, governing body meeting minutes, and patient rights information in the hospital admission packet and on posters, it was determined the hospital's governing body failed to ensure an effective grievance process was established, necessary to appropriately identify, document and resolve grievances and complaints. This failure directly impacted 8 of 10 grievances which were identified and documented by the hospital and had the potential to impact all patients and their representatives receiving hospital services. This resulted in a failure of the hospital to ensure patients' rights were upheld and promoted. Findings include:

1. The hospital's grievance policy, "Resolution of Patient Complaints/Grievance," dated 01/09, was reviewed. The grievance processes were not sufficiently developed and implemented.

a. The grievance policy stated "the Governing Body delegated the responsibility for the resolution of patient grievances to the administrator of the hospital. The administrator shall implement the processes outlined within the policy."

The policy did not include resolution of grievances by the governing body or delegation to a committee.

The Regional Director of Quality & Risk Management and the Director of Clinical Programs and Resources were interviewed together on 5/27/15 at 9:00 AM. The Regional Director of Quality & Risk Management confirmed there was no grievance committee. She stated governing body members were informally involved on a day to day basis rather than in a formal committee.

The hospital failed to ensure the grievance policy and procedure was sufficiently developed.

b. The grievance policy stated the patient would be notified of the process for filing a complaint and/or grievance.

Patient Rights documents, included in the admission packet, were reviewed. The documents, including "Patient's Rights" and "Your Right to File a Grievance Please let us know...", did not state how patients or their representatives were to file a written complaint/grievance to the hospital, except as it related to suspicions of discrimination. Further, the Patient Rights posters, in the hospital waiting area, did not include information on how to file a written or verbal grievance to the hospital, except as it related to concerns about patient privacy.

This information was confirmed by the Regional Director of Quality and Risk Management during an interview on 5/27/15 at 11:00 AM.

The hospital failed to ensure patient rights documents contained comprehensive information in accordance with the hospital's grievance policy. The hospital failed to ensure the grievance policy was implemented.

c. The grievance policy stated that any employee should immediately attempt to resolve any complaint. If the issue was not resolved, the employee's immediate supervisor should be notified immediately and a hospital incident report should be implemented.

The Regional Director of Quality & Risk Management was interviewed on 5/27/15 at 11:00 AM. She stated complaints/grievances were being captured through verbal processes during daily heads up meetings that included nursing and administration, rather than documentation on incident reports as indicated in policy.

The hospital failed to ensure the grievance policy was implemented.

d. The grievance policy stated it was the role of the employee to complete an incident report at the time of the identification of a patient grievance and forward the incident report to his or her immediate supervisor for action.

A staff RN was interviewed on 5/27/15 at 1:15 PM. When asked how she handled complaints, she stated she attempted to resolve any complaint, and if she was unable to do so, she would verbally report the concern to her nurse manager. She stated she would not complete an incident report.

The RN's nurse manager was interviewed on 5/27/15 at 2:00 PM. When asked how she handled RN reports of patient complaints, she stated she tried to resolve the concern herself, and if she was unable to do so, she would verbally report the patient concern to "quality" or to the CEO. She stated she did not usually keep records of complaints or document them on an incident report.

The DNO was interviewed on 5/26/15 at 3:00 PM. When asked if it was her practice to document grievances, she stated she did not document grievances, rather she reported unresolved grievances verbally to the compliance officer.

Incident reports were not completed at the time of the identification of a patient grievance in accordance with hospital policy. The hospital failed to ensure the grievance policy was implemented.

e. The grievance policy stated it was the role of the employee's supervisor to document on, or in an attachment to, the incident report, actions taken.

There was no documentation of actions taken, attached to incident reports, in response to grievances. This was confirmed by the Regional Director of Quality & Risk Management on 5/27/15 at 11:00 AM.

The hospital failed to ensure the grievance policy was implemented.

f. The grievance policy stated that documentation regarding the communication, steps, and efforts at resolution would be documented and attached to the hospital incident report. The policy further stated it was the role of administration to provide written follow-up at the completion of the investigation to the patient and family and the written notice should not exceed 14 days. The policy stated if the investigation exceed 14 days, a written notice summarizing the current status and a final summary should be provided no later than another 14 days (28 days total).

When asked for any documentation related to grievances, the information provided included a "Clinical Process Scoreboard" for 2014, which documented 9 grievances in 2014, documentation that related to 3 grievances in 2014 and 2015, and three letters of response. These included one letter of response to a patient grievance in 2014, one letter of response for a grievance in 2015, and one letter of response related to a billing complaint in 2014 (not a grievance).

There was no information provided related to 7 grievances referenced on the "Clinical Process Scoreboard" for 2014. There were no letters of response provided related to 8 total grievances documented in 2014 and 2015.

During an interview on 5/27/15 at 11:00 AM, the Regional Director of Quality & Risk Management confirmed documentation was missing related to grievances reported on the "Clinical Process Scoreboard."

The hospital failed to ensure the grievance policy was implemented.

g. The grievance policy stated it was the role of the risk manager to log the grievance, ensure the grievance process was completed per policy, and trend, analyze, and report through the quality improvement structure.

There was no evidence, beyond numbers of complaints/grievances, of trending or analysis of grievances/complaints for purposes of performance improvement through the hospital's quality program. This was confirmed by the Regional Director of Quality & Risk Management on 5/27/15 at 11:00 AM.

The hospital failed to ensure the grievance policy was implemented.

Based on review of patient rights information and hospital policy, and staff interview, it was determined the hospital failed to establish a clearly explained procedure for the submission of patients' written or verbal grievances to the hospital. This had the potential to interfere with patients' exercising their right to file a grievance. Findings include:

The hospital's grievance policy, "Resolution of Patient Complaints/Grievance," dated 01/09, was reviewed. The hospital's grievance policy stated the patient would be notified of the process for filing a complaint and/or grievance.

Patient Rights documents were reviewed that were included in the patient admission packet. They were titled "Patient's Rights" and "Your Right to File a Grievance Please let us know...." They did not include information on how to file a written complaint/grievance to the hospital except as they related to discrimination.

The Patient Rights poster, in the hospital waiting area, was observed. It did not include information on how to file a written or verbal grievance to the hospital except as it related to violations of privacy.

This information was confirmed by the Regional Director of Quality and Risk Management during an interview on 5/27/15 at 11:00 AM.

The hospital did not communicate a clearly explained procedure for the submission of a verbal and written grievance to the hospital.

Based on staff interview and review of hospital policies, patient rights information and grievance documentation, it was determined the hospital failed to communicate a time frame for response to grievances to patients and representatives that was consistent with hospital policy. The hospital also failed to respond within the specified time frame for 8 of 10 documented grievances. This resulted in patients/representatives not being informed of what to expect related to the grievance process and in patients/representative not receiving written responses within a specified time frame. Findings include:

1. The hospital's grievance policy, "Resolution of Patient Complaints/Grievances," dated 01/09, was reviewed. The policy outlined the following time frames for review and response of grievances:

- The patient/family will be notified within three working days of
a. the status of the grievance,
b. the investigation that has been initiated, and
c. the expected time frame for resolution.

- The patient/family will have communication from a department manager and/or case manager at least every three days

- Documentation regarding the communication, steps, and efforts at resolution will be documented and attached to the hospital incident report.

- In most instances the grievance should be resolved within seven days.

- Written notice will be provided at the earliest possible time, but should not exceed 14 days.

- Should the investigation exceed 14 days, a written notice summarizing the current status AND a final summary should be provided no later than another 14 days (28 days total).

Patient rights handouts from the patient admission packet were reviewed. Information in the packet addressed grievances related to "Section 504 Grievance Procedure" (discrimination based on disability) which allowed 30 days to respond. The handouts did not address time frames for response to other types of grievances.

The Regional Director of Quality & Risk Management was interviewed on 5/27/15 at 11:00 AM. She stated the hospital had 30 days to respond.

The information referenced in grievance policy differed from the information provided to patients related to time frames for review and response to grievances.

The hospital failed to ensure consistent, comprehensive information, related to grievance time frames was provided to patients.

2. Information was requested related to all grievance documentation from 2014 and 2015. Three letters of resolution were provided, one for a grievance in 2014, one for a grievance in 2015, and one for a billing complaint in 2014. A "Clinical Process Scoreboard" for 2014, attached to governing body meeting minutes, was also provided. The scoreboard documented 9 grievances were reported to the governing body in 2014. Specific information related to the grievances was not included on the scoreboard. A similar scoreboard was not provided for 2015.

There was no documentation of letters of resolution for 8 of the 9 grievances referenced on the scoreboard for 2014.

This was confirmed by the Regional Director of Quality & Risk Management during an interview on 5/27/15 at 11:00 AM.

The hospital did not review, investigate, and resolve grievances within a time frame specified in policy.

Based on review of grievance documentation, hospital policy, and staff interview, it was determined the hospital failed to ensure patients were provided with written responses to 8 of 10 documented grievances. This resulted in an incomplete grievance process and a failure to inform patients in writing of resolutions to grievances. Findings include:

The hospital's grievance policy, "Resolution of Patient Complaints/Grievances," PR 020, dated 1/09, was reviewed. It provided the following information related to communication of grievance resolution:

"The administrator will provide a written notice of the decision involving the grievance, including:

- Steps taken on behalf of the patient to resolve the grievance;

- The results of the steps and investigation;

- The date of completion/closure of the grievance; and

- The name and contact of the administrator for further follow up or questions."

Information was requested related to all grievance documentation from 2014 and 2015. Three letters of resolution were provided, one for a grievance in 2014, one for a grievance in 2015, and one for a billing complaint in 2014 (not a grievance). A "Clinical Process Scoreboard" for 2014, attached to governing body meeting minutes, was also provided. The scoreboard documented 9 grievances were reported to the governing body in 2014. Specific information on the grievances was not included on the scoreboard. A similar scoreboard was not provided for 2015. There was no documentation of letters of resolution for 8 documented grievances in 2014.

This was confirmed by the Regional Director of Quality & Risk Management during an interview on 5/27/15 at 11:00 AM.

Written notice was not provided for 8 of 10 documented grievances in 2014 and 2015.

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Based on review of hospital policy and medical records, and staff interview, it was determined the hospital failed to ensure policies and procedures were developed and implemented to address the use of behavioral restraint for 1 of 1 patient (#3) reviewed, whose record documented behavioral restraint use. This failure resulted in a patient being subjected to behavioral restraints contrary to hospital policy and being kept in restraints without justification for use. Findings include:

1. The hospital policy, "Restraint Use PC 200," dated 11/14, was reviewed. The policy stated that "behavioral restraints" were prohibited from use at any time within the organization. However, Patient #3's record documented he has been restrained in response to violent and/or self destructive behavior as follows:

Patient #3 was a 41 year-old male admitted to the hospital on 2/06/15, at 2:04 PM. His discharge summary, dated 2/17/15, stated his diagnoses included severe anoxic brain injury, type 1 diabetes mellitus bipolar disorder and a history of obstructive sleep apnea.

According to the discharge summary, Patient #3 was found unresponsive in his home on 11/29/14, when his blood sugars were found to have been between 16 and 23 for many hours, which resulted in the diagnosis of severe anoxic brain injury. The discharge summary also stated Patient #3 was "noted to have severe agitation throughout his hospitalization."

A physician order titled "Restraint Orders," dated 2/06/15 at 10:00 PM, initiated and signed by an RN, was signed by the physician on 2/27/15 and included the section "MEDICAL RESTRAINT CRITERIA." Documentation within this section included "Assessment of Behaviors." A list of various behaviors, with check boxes were included. The box beside the word "Other" was checked and stated, "Pt. trying to climb out of bed and interfering with cares. Pt. risk to self and others."

The physician restraint order form also included a section titled, "PHYSICIAN RESTRAINT ORDERS," with sub-sections marked 1 through 5, as follows:

- Clinical justification for restraint: The box beside the word "Medical" was checked.

- Restraint Type: The boxes beside right arm, left arm, right leg and left leg were checked.

- Written orders for Restraints are limited to: The box beside 1 Calendar Day was checked.

- Assess and release Restraint per hospital policy. The box was checked beside this statement.

- Initiate and/or to modify interdisciplinary Plan of Care. The box beside this statement was checked.

Patient #3's record documented he was restrained, as follows:

The "NIGHT SHIFT NURSING PROGRESS NOTE," written by an RN on 2/06/15, included the following:

- 8:45 PM "Patient grabbing at insulin needles. Pt. yelling and kicking at the foot of the bed. Pt. has restraints x 4 in place."

- 9:45 PM "MD called to get restraint order, Pt. is wild, yelling, kicking at bed..."

The "NIGHT SHIFT NURSING PROGRESS NOTE," written by an RN on 2/07/15, included the following:

- 8:00 AM "Pt. trying to kick and climb out of bed, spitting, tone of voice is agitated and aggressive. Pt. is in restraints x 4..."

- 10:00 AM "Pt. continues to slide up and down in bed, trying to climb out."

- 2:00 PM "Pt. sliding around in bed, pulling at restraints."

- 6:00 PM "Pt. thrashing in bed. Spits applesauce with meds out on floor."

- 9:00 PM "...Pt. agitated swearing at staff."

The DNO was interviewed on 5/28/15, beginning at approximately 10:00 AM. She confirmed restraints were used for Patient #3 to manage aggressive and/or self-destructive behavior.

The hospital failed to ensure the practice of using behavioral restraints for the management of violent or self-destructive behavior that jeopardized the immediate physical safety of the patient, staff member, or others was incorporated into hospital policy.

Additionally, the hospital restraint policy stated patients were to be released from restraints at the earliest possible time. However, Patient #3's record did not demonstrate that the behavioral restraints were discontinued at the earliest possible time, as follows:

Nursing progress notes documented restraints were initially implemented on 2/06/15 at 8:00 PM and were not discontinued until 2/17/15 at 3:30 PM, when Patient #3 became unresponsive.

The "NIGHT SHIFT NURSING PROGRESS NOTE," written by an RN on 2/06/15, included the following:

- 11:50 PM "Pt. awake, calm, Restraint x 4..."

- 3:30 AM "Pt. sleeping. No s/s of pain or distress noted...Restraints x 4."

- 5:30 AM "...Pt. sleeping, restrained x 4..."

- 6:00 AM "Pt. remains in restraints due to risk of injury to self and others."

The record did not document how Patient #3 remained at "risk of injury to self and others" when he was calm and/or sleeping.

The "NIGHT SHIFT NURSING PROGRESS NOTE," written by an RN on 2/07/15, included the following:

- 12:00 PM "Pt. asleep in bed. in no acute distress.

- 4:00 PM "Pt. asleep in no acute distress."

Patient #3 remained in 4 point restraints (soft cuffs placed around his wrists and ankles which were then tied to Patient #3's hospital bed to limit movement) during these documented times of calm behavior and sleep.

"Restraint Flow Sheets" indicated restraints were initially implemented on 2/06/15 at 8:00 PM and were not discontinued until 2/17/15 at 4:00 PM, when Patient #3 became unresponsive.

A "Restraint Flow Sheet," dated 2/06/15 at 8:00 PM, documented Patient #3 was calm or sleeping from 12:00 AM through 6:00 AM, but remained in restraints.

On 2/07/15, the "Restraint Flow Sheet" documented Patient #3 was asleep or calm at 12:00 PM, 4:00 PM, 8:00 PM, 2:00 AM and 6:00 AM. The form indicated Patient #3 remained in 4 point restraints.

Another "Restraint Flow Sheet,"dated 2/11/15, documented Patient #3 was "less agitated" at 10:00 AM, 12:00 PM and 4:00 PM. The form stated he was "calm" from 2:00 AM until 6:00 AM. The flow sheet documented Patient #3 remained in 4 point restraints during these times.

The DNO was interviewed on 5/28/15, beginning at approximately 10:00 AM. She confirmed documention did not support Patient #3 was released from restraints at the earliest possible time.

The facility failed to ensure restraints to manage violent or self-destructive behavior were addressed in facility policy and discontinued at the earliest possible time.

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Based on review of hospital policy and medical records, and staff interview, it was determined the hospital failed to ensure physicians were contacted immediately after emergency application of restraints in 1 of 2 restrained patients (#3) whose records were reviewed. This resulted in unauthorized restraint use. Findings include:

1. The hospital policy, "Restraint Use - PC 200," dated 11/14, stated: "A registered nurse may assess the immediate need for restraint and apply restraints without the order of a physician. The Physician/LIP must be notified of the use of restraint as soon as possible after application, but within 30 minutes of its application. If the initiation of the restraint is based on a significant change in the patient's condition, the physician will be notified immediately."

A nurse manager identified as the primary restraint trainer was interviewed on 5/28/15 at 10:00 AM. She confirmed 30 minutes were allowed to get an order after the application of a restraint.

The hospital failed to ensure the restraint use policy required that the physician/LIP be immediatly notified (within a few minutes) of emergency restraint use.

2. Patient #3 was a 41 year-old male admitted to the hospital on 2/06/15, at 2:04 PM. His discharge summary, dated 2/17/15, stated his diagnoses included severe anoxic brain injury, type 1 diabetes mellitus bipolar disorder and a history of obstructive sleep apnea.

According to the discharge summary, Patient #3 was found unresponsive in his home on 11/29/14, when his blood sugars were found to have been between 16 and 23 for many hours, which resulted in the diagnosis of severe anoxic brain injury. The discharge summary also stated Patient #3 was "noted to have severe agitation throughout his hospitalization."

Patient #3's Nursing progress notes indicated restraints were initially implemented on 2/06/15 at 8:00 PM. Physician orders for initiation of restraints were documented on 2/06/15 at 10:00 PM.

The hospital failed to obtain a physician order until 2 hours after 4 point restraints were initiated, resulting in unauthorized restraint usage.

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Based on review of medical records and hospital policy, and staff interview, it was determined the hospital failed to ensure a behavioral restraint did not exceed 4 hours for 1 of 1 patient (#3) who was restrained to manage violent behavioral whose medical record was reviewed. This resulted in a patient being restrained longer than the maximum 4 hours allowed for restraints used to manage violent behavior. Findings include:

The hospital policy, "Restraint Use PC 200," dated 11/14, stated that "behavioral restraints" were prohibited from use at any time within the organization.

A nurse manager identified as the primary restraint trainer was interviewed on 5/28/15 at 10:00 AM. When asked if the hospital used behavioral restraints, she stated that it was sometimes necessary to use behavioral restraints to protect staff from patients who were hitting or biting. She explained that behavioral restraints had occasionally been necessary with patients who were mentally handicapped or brain injured or who had medical issues that caused acting out behaviors.

Patient #3's record documented he has been restrained in response to violent and/or self destructive behavior as follows:

Patient #3 was a 41 year-old male admitted to the hospital on 2/06/15, at 2:04 PM. His discharge summary, dated 2/17/15, stated his diagnoses included severe anoxic brain injury, type 1 diabetes mellitus bipolar disorder and a history of obstructive sleep apnea.

According to the discharge summary, Patient #3 was found unresponsive in his home on 11/29/14, when his blood sugars were found to have been between 16 and 23 for many hours, which resulted in the diagnosis of severe anoxic brain injury. The discharge summary also stated Patient #3 was "noted to have severe agitation throughout his hospitalization."

A physician order titled "Restraint Orders," dated 2/06/15 at 10:00 PM, initiated and signed by an RN, was signed by the physician on 2/27/15 and included the section "MEDICAL RESTRAINT CRITERIA." Documentation within this section included "Assessment of Behaviors." A list of various behaviors, with check boxes were included. The box beside the word "Other" was checked and stated, "Pt. trying to climb out of bed and interfering with cares. Pt. risk to self and others."

The physician restraint order form also included a section titled, "PHYSICIAN RESTRAINT ORDERS," with sub-sections marked 1 through 5, as follows:

- Clinical justification for restraint: The box beside the word "Medical" was checked.

- Restraint Type: The boxes beside right arm, left arm, right leg and left leg were checked.

- Written orders for Restraints are limited to: The box beside 1 Calendar Day was checked.

- Assess and release Restraint per hospital policy. The box was checked beside this statement.

- Initiate and/or to modify interdisciplinary Plan of Care. The box beside this statement was checked.

Patient #3's record documented he was restrained, as follows:

The "NIGHT SHIFT NURSING PROGRESS NOTE," written by an RN on 2/06/15, included the following:

- 8:45 PM "Patient grabbing at insulin needles. Pt. yelling and kicking at the foot of the bed. Pt. has restraints x 4 in place."

- 9:45 PM "MD called to get restraint order, Pt. is wild, yelling, kicking at bed..."

The "NIGHT SHIFT NURSING PROGRESS NOTE," written by an RN on 2/07/15, included the following:

- 8:00 AM "Pt. trying to kick and climb out of bed, spitting, tone of voice is agitated and aggressive. Pt. is in restraints x 4..."

- 10:00 AM "Pt. continues to slide up and down in bed, trying to climb out."

- 2:00 PM "Pt. sliding around in bed, pulling at restraints."

- 6:00 PM "Pt. thrashing in bed. Spits applesauce with meds out on floor."

- 9:00 PM "...Pt. agitated swearing at staff."

Nursing progress notes indicated restraints were initiated on 2/06/15 at 8:45 PM and remained in place until 2/17/15 at 3:30 PM.

The DNO was interviewed on 5/28/15, beginning at approximately 10:00 AM. She confirmed restraints were used for Patient #3 to manage aggressive and/or self-destructive behavior.

The hospital failed to ensure orders for and implementation of restraints for the management of violent or self-destructive behavior that jeopardized the immediate physical safety of the patient, a staff member, or others did not exceed 4 hours.

Based on record review, staff interview and review of policies, it was determined the hospital failed to ensure the medical records of 1 of 2 sample patients (#3) who were physically restrained, included documentation of the rationale for continued use. The lack of documentation had the potential to prevent staff from effectively assessing the need for continued use of restraints. Findings include:

Patient #3 was a 41 year-old male admitted to the hospital on 2/06/15, at 2:04 PM. His discharge summary, dated 2/17/15, stated his diagnoses included severe anoxic brain injury, type 1 diabetes mellitus bipolar disorder and a history of obstructive sleep apnea.

According to the discharge summary, Patient #3 was found unresponsive in his home on 11/29/14, when his blood sugars were found to have been between 16 and 23 for many hours, which resulted in the diagnosis of severe anoxic brain injury. The discharge summary also stated Patient #3 was "noted to have severe agitation throughout his hospitalization."

The hospital restraint policy stated "Clinical assessment/justification must identify that the patient presents with unsafe behavior, is not cognitively intact, is placing self and others at risk adn/or the patient may disrupt essential medical itnerventions (i.e., dialysis, intravenous therapy, tube feeding, etc)." However, Patient #3's record did not demonstrate clinical assessment and justification for continued use of restraints, as follows:

"Restraint Flow Sheets" indicated restraints were initially implemented on 2/06/15 at 8:00 PM and were not discontinued until 2/17/15 at 4:00 PM, when Patient #3 became unresponsive.

A "Restraint Flow Sheet," dated 2/06/15 at 8:00 PM, documented Patient #3 was calm or sleeping from 12:00 AM through 6:00 AM, but remained in restraints.

On 2/07/15, the "Restraint Flow Sheet" documented Patient #3 was asleep or calm at 12:00 PM, 4:00 PM, 8:00 PM, 2:00 AM and 6:00 AM. The form indicated Patient #3 remained in 4 point restraints.

Another "Restraint Flow Sheet,"dated 2/11/15, documented Patient #3 was "less agitated" at 10:00 AM, 12:00 PM and 4:00 PM. The form stated he was "calm" from 2:00 AM until 6:00 AM. The flow sheet documented Patient #3 remained in 4 point restraints during these times.

The DNO was interviewed on 5/28/15, beginning at approximately 10:00 AM. She confirmed documention did not include justification for continued use of restraints for Patient #3.

The facility failed to ensure Patient #3's medical record included the rationale for continued use of restraints.

Based on staff interview and policy review, it was determined the hospital failed to define qualifications for restraint trainers to ensure appropriate education, training, and experience associated with the use of restraints. This had the potential to allow unqualified staff to serve as restraint trainers. Findings include:

The hospital policy, "Restraint Use - PC 200," dated 11/14, stated that personnel who provided training to staff regarding the use, application, and assessment of restraints must be qualified by virtue of education, training, and experience associated with the use of restraints. At a minimum, persons providing the training will be either a registered nurse or LIP. The policy did not define what constituted acceptable training and experience required to be a restraint trainer.

A nurse manager, identified as the primary restraint trainer, was interviewed on 5/28/15 at 10:00 AM. She stated she did most of the restraint training at nursing staff orientation and annual staff education. She also stated RNs who had successfully completed the orientation could serve as restraint trainers.

The agenda for nursing orientation, titled "Nursing/PCT Department Orientation" was reviewed. It allotted 30 minutes for restraint orientation by a nurse manager between 11:30 AM - 12:00 PM. It could not be determined how a 30 minute orientation could qualify an RN to become a restraint trainer.

There was insufficient evidence that RNs permitted to serve as restraint trainers were qualified as evidenced by education, training, and experience in techniques used to address patients' behaviors.

30581

Based on review of hospital policy and medical records, and staff interview, it was determined the hospital failed to ensure a death was tracked for 1 of 1 patient (#3) reviewed whose death occurred within 24 hours of a patient being removed from 2-point, soft wrist restraint. This had the potential to interfere with the hospital's analysis and improvement activities through the hospital's quality assessment performance improvement activities. Findings include:

1. The hospital's policy, "Restraint Use - PC 200," dated 11/14, stated "Deaths that occur when the only restraints used on the patient are wrist restraints composed solely of soft, non-rigid, cloth-like material do not have to be reported to CMS, but the hospital does the following:

a. Records in the incident reporting system any death that occurs while a patient is in the soft wrist restraint within seven days of the patient death;

b. Records in the incident reporting system any death that occurs within 24 hours after a patient has been removed from soft wrist restraint within seven days of the patient death;

c. Documents in the patient medical record the date and time that the death was recorded in the incident report system by the risk manager or designee;

d. Documents in the incident report system, the patient's name, date of birth, date of death, name of attending physician or other licensed independent practitioner responsible for the care of the patient, medical record number, and primary diagnosis;

e. Makes available to CMS the incidents related to deaths in soft wrist restraints upon request."

The policy was not implemented as follows:

Patient #3 was a 41 year-old male admitted to the hospital on 2/06/15, at 2:04 PM. His discharge summary, dated 2/17/15, stated his diagnoses included severe anoxic brain injury, type 1 diabetes mellitus bipolar disorder and a history of obstructive sleep apnea.

According to the discharge summary, Patient #3 was found unresponsive in his home on 11/29/14, when his blood sugars were found to have been between 16 and 23 for many hours, which resulted in the diagnosis of severe anoxic brain injury. The discharge summary also stated Patient #3 was "noted to have severe agitation throughout his hospitalization."

Nursing progress notes indicated restraints were initiated on 2/06/15 at 8:45 PM and remained in place until 2/17/15 at 3:30 PM.

A NIGHT SHIFT PROGRESS NOTE, dated 2/16/15 at 7:15 PM and completed by and RN, stated "...Bilateral soft wrist restraints in place..."

A DAY SHIFT NURSING PROGRESS NOTE, dated 2/17/15 at 3:30 PM and completed by an RN, stated "restraints DC'd..."

A NIGHT SHIFT NURSING PROGRESS NOTE, dated 2/17/15 at 11:40 PM and completed by and RN, stated "0 pulse 0 respirations...Family notified."

The "DISCHARGE SUMMARY," dated 2/17/15 and completed by a physician, indicated Patient #3 died at "approximately" 11:40 PM.

The hospital did not document in Patient #3's medical record the date and time the death report entry was made into a log or tracking system.

The Regional Director of Quality & Risk Management was interviewed on 5/28/15 at 10:00 AM. When asked about the hospital's tracking system for deaths that qualify for entry in an internal log, she stated the deaths were tracked in the incident reporting system. She reviewed the incident reports and stated there were no documented incidents of patient deaths involving patients who had been restrained at or near the time of death.

The hospital failed to ensure the death of a patient, who expired within 24 hours of release from restraints, was tracked in an internal log or incident reporting system.

Based on review of hospital policy and patient rights information, and staff interview, it was determined the hospital failed to ensure patients (or support persons, where appropriate) were clearly informed of the right to receive visitors of choice and the right to withdraw or deny such consent at any time. This resulted in incomplete disclosure of rights and had the potential to interfere with the exercise of rights. Findings include:

The hospital policy, "Visitors - PR 055," dated 1/12, stated "Visitors that are encouraged include any person designated including, but not limited to a spouse, a domestic partner (including same-sex domestic partners), another family member, and/or a friend. The hospital will not restrict, limit, or otherwise deny visitation on the basis of race, color, national origin, religion, sex, gender identity, sexual orientation, or disability. Visitors will be provided full and equal visitation based on individual patient preferences."

A patient handout, "Visitors," was reviewed that was included in the patient admission packet. It stated "you are encouraged to have friends and family visit while a patient at the hospital." It did not specify the patient's right to receive the visitors whom he or she designated, including, but not limited to, a spouse, a domestic partner, including a same sex domestic partner. It also did not communicate the patient's right to withdraw or deny consent at any time.

The Regional Director of Quality & Risk Management and the Director of Clinical Programs and Resources were interviewed together on 5/27/15 at 9:00 AM. The Regional Director of Quality & Risk Management confirmed the patient handout information did not specifically inform patients of the right to withdraw or deny visitation consent or the right to inform patients to receive designated visitors, including, but not limited to, a spouse, a domestic partner (including a same-sex domestic partner), another family member or friend. She stated the bill of rights information, separate from the visitor information, did include the general right to designate who may may be permitted to visit them.

Based on medical record review and staff interview, it was determined the hospital failed to ensure nursing staff monitored patients' respiratory rates, in accordance with standards of practice for narcotic administration, for 5 of 10 patients (#1, #6, #7, #8 and #9) whose medical records were reviewed. This had the potential to interfere with patient safety. Findings include:

There was no documentation respiratory rates were assessed for patients whose MAR included instructions to hold medication for a respiratory rate less than 12 or for excessive sedation.

1. Patient #1's MAR documented PRN orders, dated 6/13/14, for Hydrocodone 5/325 mg 1-2 tablets as needed for moderate pain. The medication was administered without evidence Patient #1's respiratory rate had been assessed prior to administration of the medication during the following times: 6/13/14 at 6:30 PM, 6/14/14 at 7:30 AM and 10:45 PM, 6/15/14 at 6:00 AM, 11:00 A.M., and 10:00 PM, 6/16/14 at 1:00 PM, 6/17/18 at 2:05 PM and 8:00 PM, 6/18/15 at 2:30 AM and 6:30 AM, 6/19/15 at 8:45 AM and 9:04 PM, 06/20/15 at 4:00 AM and 11:00 AM.

2. Patient #6's MAR documented scheduled orders, dated 5/12/15 for Morphine SR tablet 15 mg every eight hours. The medication was administered without evidence Patient #6's respiratory rate had been assessed prior to administration of the medication, as instructed on the MAR, during the following times: 5/21/15 at 2:00 PM and 10:00 PM, 5/23/15 at 2:00 PM and 10:00 PM, 5/24/15 6:00 AM, 2:00 PM and 10:00 PM, 5/25/15 at 6:00 PM, 5/26/15 at 2:00 PM, and 5/27/15 at 6:00 PM.

Patient #6's MAR documented PRN orders, dated 4/23/15, for Oxycodone tablet 10 mg every 3 hours as needed for severe pain. The medication was administered without evidence Patient #6's respiratory rate had been assessed prior to administration of the medication, as instructed on the MAR, during the following times: 5/23/15 at 12:30 PM and 9:30 PM, 5/24/15 at 12:20 PM and 5:30 PM, 5/25/15 at 8:30 AM and 11:25 PM, and 5/26/15 at 12:50 PM.

The hospital failed to ensure nursing staff monitored patients' respiratory rates, as instructed on the MAR, for narcotic medication.

Patient #6's MAR documented PRN orders, dated 5/12/15, for Fentanyl 50 mcg every 6 hours as needed for severe pain not relieved with oxycodone. The medication was administered on 5/22/15 at 1:20 PM without evidence Patient #6's respiratory rate had been assessed prior to administration of the medication.

3. Patient #7's MAR documented PRN orders, dated 5/22/15, for Hydrocodone-APA 10/325 mg every 4 hours as needed for moderate pain. The medication was administered without evidence Patient #7's respiratory rate had been assessed prior to administration of the medication, as instructed on the MAR, during the following times: 5/23/15 at 1:40 PM, 5/24/15 at 2:30 PM, and 5/25/15 at 8:05 AM and 2:15 PM.

4. Patient #8's MAR documented PRN orders, dated 3/12/15, for Oxycodone 10 mg every four hours as needed for severe pain. The medication was administered without evidence Patient #8's respiratory rate had been assessed prior to administration of the medication, as instructed on the MAR, during the following times: 3/12/15 at 9:43 PM, 3/13/15 at 2:00 PM, 3/15/15 at 5:10 PM, 3/16/15 at 11:00 AM and 6:00 PM, 3/19/15 at 11:35 AM, and 3/21/15 at 3:40 PM.

5. Patient #9's MAR documented PRN orders, dated 5/24/15, for Hydrocodone-APAP 7.5/325 mg, 2 tablets every 4 hours as needed for severe pain. The medication was administered without evidence Patient #9's respiratory rate had been assessed prior to administration of the medication, as instructed on the MAR, during the following times: 5/24/15 at 8:40 AM, 2:30 PM and 8:00 PM, 5/25/15 at 5:40 AM, 5/26/15 at 8:30 AM and 2:00 PM, and 5/27/15 at 9:30 AM and 2:45 PM.

A nurse manager was interviewed on 5/27/15 at 2:00 PM. When asked if she expected respiratory rates to be assessed and documented when indicated on MAR, she stated nursing staff was expected to assess respiratory rate and document it on the MAR or the graphic sheet. She stated if the respiratory rate had been assessed within 30 minutes, it was not necessary to assess again at the time of administration of medication.

The DNO was interviewed on 5/26/15 at 3:00 PM. When asked about the expectation for nursing staff to assess respiratory status prior to administration of narcotic medication, she stated respiratory rates were generally documented on the graphic sheet, that they may or may not be documented if the rates were within an acceptable range. She confirmed the records did not document evidence respiratory rates had been assessed.

A pharmacist who was also the CEO was interviewed on 5/27/15 at 11:55 AM. He it was a standard of practice to assess respiratory rate for specific medications, and the information was inserted into the MAR, if relevant, based on industry standard. During a second interview on 5/27/15 at 12:15 PM, the CEO stated the director of pharmacy and the medical director informally approved the insert to not give the medication if the respiratory rate was below 12 for certain medications, such as narcotics. He stated it was not formally established in policy.