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During the EMTALA complaint investigation it was determined a deficient practice had occurred related to Patients Rights. The surveyors contacted the state agency (SA) for further guidance on July 22, 2015. On the direction of the Centers for Medicare and Medicaid Services (CMS) Regional Office (RO) additional Conditions of Participation (CoP) were opened under 42 CFR Part 482: Conditions of Participation for Hospitals (Rev 141; July 15, 2015). Additional areas for investigation were opened to include 482.13 Patient Rights and 482.21 Quality Assurance and Performance Improvement (QAPI). The investigation was initiated on July 22, 2015 and completed July 28, 2015 through July 30, 2015.

Observations, interviews, document review, and investigation determined the facility's non-compliance related to Patient Rights, resulted in Immediate Jeopardy (IJ). The onsite Medical Facilities Inspectors investigated and communicated the findings to the State Agency (SA) office at 3:10 p.m. on July 29, 2015. With SA approval, the facility's administrative staff (Staff #2, #3 and #7) was informed of the IJ at 4:49 p.m. on July 29, 2015. The surveyors requested the hospital staff prepare a plan of removal for the IJ.

On July 29, 2015 at approximately 6:03 p.m. Staff #2, Staff #3 and Staff #7 presented a plan to remove the immediacy associated with the IJ. That component involved the reassessment of the currently restrained patients and working "towards an environment that is as restraint free as possible" by 7:00 p.m. on July 29, 2015. The other components presented by Staff #2, Staff #3 and Staff #7 included: The immediate establishment of a "Restraint Leadership Team" that would be notified upon the initiation of all new restraints, The immediate implementation of nursing supervisor rounds each shift in the Emergency Department (ED) and Behavioral Health unit to ensure compliance with facility restraint policy. Staff #2 verbally included nursing supervisor rounding on all units to ensure compliance with facility restraint policy. The "Immediate Action Plan" included Nursing leadership's development of patient restraint logs to be completed every shift and reviewed for compliance by the restraint leadership team and an education component. The plan indicated a release of key talking points regarding the use of restraints to all nursing and medical staff as well as a dedicated full time educator to develop and implement a comprehensive restraint use competency for all appropriate staff. Staff #2 presented the education "key talking points" to the surveyors.

At 7:05 p.m. on July 29, 2015, Staff #2, Staff #3 and Staff #7 indicated the restrained patients had been reassessed by their physicians and were restraint free. A tour of the unit was conducted at 7:15 p.m. on July 29, 2015 both patients had been removed from restraints. When the surveyors determined there were no patients in seclusion or restraints and credible evidence had been presented for current evening shift employees; a call was placed to the SA at 8:25 p.m. on July 29, 2015. Under the direction of the SA the surveyors removed the immediacy component of the IJ at 8:45 p.m. on July 29, 2015.

The following credible evidence was submitted to the surveyors on July 30, 2015:
At 8:45 a.m. the night shift nursing supervisor audits and additional unit staff education.
At 10:22 a.m. Physician notification with selected proof of Physician response that restraint education had been delivered.
At 10:30 a.m. a letter from the facility's chief executor authorizing the action plan and commitment of implementation.
At 10:30 a.m. a letter documenting the facility had remained restraint free during the evening of July 29, 2015.
At 1:01 p.m. a signed attendance sheet of the Restraint Leadership Team, initial meeting and key talking points related to restraints held on July 29, 2015.

A tour was conducted on July 30, 2015 from 1:05 p.m. to 1:20 p.m., with Staff #3, Staff #7 and the surveyor; of the facility's Emergency Department (ED), Intensive Care and Behavioral Health units. Patient observations and staff interviews provided evidence the facility had no restrained patients at that time. A call was placed to the SA and IJ was lifted at 1:27 p.m. on July 30, 2015. The surveyors informed Staff #1, Staff #2, Staff #3 and Staff #7 of the SA's decision to remove the Immediate Jeopardy.

Identified concerns related to Patient Rights:

Facility staff used medications as a chemical restraint to manage a patient's behavior. (See Citation 0160 for further details)

The interdisciplinary team failed to revise patient's plan of care to address the utilization of restraints. (See Citation 0164 for further details)

Facility staff failed to obtain a physician or other licensed independent practitioner (LIP) order for the use of restraints. (See Citation 0168 for further details)

Facility staff implemented orders for physical restraint on a PRN (as needed) basis. (See Citation 0169 for further details)

Facility staff failed to note the rationale for the use of behavioral restraints. (See Citation 0171 for further details)

Facility staff failed to follow the hospital's policy for renewing non-behavioral restraints. (See Citation 0173 for further details)

Facility staff failed to assess and monitor Patients in restraint. (See Citation 0175 for further details)

Facility staff failed to document the patient's behavior prior to using restraints. (See Citation 0185 for further details)

Based on staff interviews, electronic medical record reviews, facility document reviews and as part of a complaint investigation, it was determined the facility's staff used medications as a restraint to manage the patient's behavior.

The findings were:

Patient #21's medical record was reviewed throughout the survey. On 05/01/15 at 12:44 pm Patient #21 presented to the Emergency Department (ED) via Emergency Medical System (EMS) escorted by Police. Patient #21 was found to have "Altered Mental Status (AMS), slurred speech and was combative with EMS and a near empty vodka bottle was found in Patients possessions." Past Medical History: "Unknown." Home Medications: "Unknown."

At 1:06 pm Haldol (Antipsychotic medication) 5 mg IM (Intramuscular) and Ativan (Anti- anxiety medication) 1 mg IM was ordered by a physician, Staff Member (SM)#27. SM#29 administered the medication at 1:19 pm. At that time he/she documented Patient #21's mental status as "awake but disoriented." SM#29 documented at 1:33 pm "pt (patient) found ambulating in halls with unsteady gait, pt was escorted back to room with assist, in route pt had a near fall but was assisted by rn (Registered Nurse), pt returned to stretcher and hooked back up to monitor." At 2:00 pm he/she documented, "pt relocated to front of nursing station in hall a." At 3:38pm he/she documented, "pt remains in stretcher resting with eyes closed, respirations even and unlabored. At 5:09 pm the nurse documented, "pt sat up, asked for some water and then went back to sleep." At 5:57 pm the same physician ordered Haldol 5 mg IM and Ativan 1 mg IM to be given. SM#29 documented the medication was given at 6:10 pm. At 6:11 pm he/she documented, "pt found ambulating out the ambulance bay, pt was returned to stretcher, pt still has unsteady gait." At 6:26 pm the nurse documented, "pt resting in stretcher, respirations even and unlabored." At 7:05 pm SM#29 documented, "report given to, care endorsed to SM#30 Rn."

At 7:30 pm SM#30 documented, "pt sleeping on stretcher in NAD, (no apparent distress) with even nonlabored respirations. Pt in hallway in front of primary RN. Moans to tactile stimuli and returns to sleep." At 9:40 pm the doctor ordered, "Ambulate Hallway." At 9:40 pm the primary nurse documented, "Pt unsteady on [his/her] feet not able to ambulate off the stretcher to take 2 steps without falling back onto stretcher with primary RN at bedside." Doctor made aware. At 9:28 pm the physician documented in his/her exam, "pt presented obtunded-smells of etoh (alcohol)-responds to painful stimuli then awoken-verbally abusive to staff-slurred speech-required chemical restraints as patient potential harm to self given high etoh intoxication. Allowed to achieve clinical sobriety. However still very unsteady on [his/her] feet. Will allow to continue to metabolize [his/her] etoh." At 10:46 pm the doctor ordered, "Haldol 5 mg IM." At 10:53 pm the primary nurse documented the medication was given. There were no chemical restraint orders found in the electronic medical record (EMR).

Patient #21 received two doses of Haldol and Ativan, with a third dose of Haldol alone.

On 07/22/15 at 9:10 am a telephone interview was conducted with SM#27. The surveyor asked the physician about the documentation that was charted in the (EMR). He/she stated they did not want to write an order for chemical restraints it was a "miss notation". Stating he/she wrote the information during the medical decision making process, but did not want to put the patient in chemical restraints. The physician stated he/she wanted to keep the patient calm and control their disruptive behavior until clinical sobriety could be achieved. The surveyor asked the physician to define a chemical restraint. He/she stated a chemical restraint was a "high dose of an abnormal medication that would put someone to sleep".

On 07/22/15 a copy of the hospital policy and procedures titled, "Use of Patient Restraints" with a last update date of 01/13, was reviewed. Under "Chemical Restraint: a drug or medication when it is used as a restriction to manage the patient's behavior or restrict the patient's freedom of movement and is not a standard treatment or dosage for the patient's condition. Medications that are therapeutic agents used to treat behavioral symptoms that comprise the patient's regular medical regimen (including PRN [as needed] medications) are not considered drug restraints when their purpose may be to calm agitation, help patient concentrate and make more accessible to interpersonal intervention. The use of this medication should be addressed in the patient's plan of care and medical record. A drug used as a restraint would put a patient to sleep, rendering them unable to function as a result of the medication."

"E. Ordering Restraints
1. Restraint will be ordered by a physician or LIP authorized by the medical staff.
2. PRN (as needed) or standing restraint orders will not be accepted and the ordering practitioner will be contacted to clarify or discontinue the order.
3. The order will specify the method of restraint to be used. (Indications for the restraint will be documented.)
4. The attending physician will be notified as soon as possible if the restraint is not ordered by the patient's attending physician."

On 07/22/15 a copy of the Medical Staff Rules and Regulations was obtained by the surveyors. The following was noted under ARTICLE X titled, "Restraints, Seclusion, and Behavior Management Programs". "Restraints, seclusion, and behavior management programs will be governed by the Hospital Policies addressing restraints, seclusion, and behavior management."

Based on interview, document review and during a complaint investigation it was determined the interdisciplinary team failed to revise the plan of care to address restraints for three (3) of twenty-seven (27) restrained patients included in the survey sample. (Patients #44, #47 and #65)

The findings included:

Review of Patient #44's electronic medical record (EMR) was conducted on July 29, 2015 at 3:08 p.m., with Staff #13. Patient #44's EMR documented the patient was admitted to the facility on June 5, 2015. Nursing documentation revealed Patient #44 was placed in "2-pt (point) wrist restraints" on June 7, 2015. Review of Patient #44's plan of care did not reveal a revision to address restraints. Staff #13 navigated Patient #44's EMR. Staff #13 stated, "If a plan had been added for restraints it would appear in the column with the other care plans. There isn't a restraint care plan. " Staff #13 verified Patient #44 had been placed in 2-point wrist restraints and staff had failed to revise the patient's plan of care to include restraints.

Review of Patient #47's EMR was conducted on July 29, 2015 at 6:32 p.m., with Staff #13. Patient #47's EMR documented the patient had been seen in the facility's emergency department on June 27, 2015 and admitted to an inpatient unit on June 28, 2015. Patient #47's EMR documented the patient was placed in bilateral soft wrist restraints at 1:05 a.m. on June 28, 2015. Staff #13 reviewed Patient #47's care plans and reported "There isn't a care plan for restraints."

Review of Patient #65's EMR was conducted on July 30, 2015 at 9:37 a.m., with Staff #13. Patient #65's EMR documented the patient was admitted to the facility on April 27, 2015. Patient #65's EMR documented the patient was placed in bilateral mitts to keep him/her from "pulling on lines" at 3:51 p.m. on April 29, 2015. Staff #13 reviewed Patient #65's care plans and stated, "There is no care plan for restraints."

Review of the facility's policy titled "Use of Patient Restraints or Seclusion" revised "07/15" read in part "Ordering restraints ... The use of restraints or seclusion must be in accordance with a written modification to the patient's plan of care ..."

An interview was conducted on July 30, 2015 at approximately 11:00 a.m. with Staff #2, Staff #3, and Staff #7. The facility staff was informed of the findings.

Based on staff interviews, electronic medical record reviews, facility document reviews and as part of a complaint investigation, it was determined the facility's staff failed to obtain, or initiate a physician or other licensed independent practitioner (LIP) order for the use of restraints for 2 of 27 restrained patients included in the survey sample. Patients #21 and #59.

The findings were:

1.. Patient #21's medical record was reviewed throughout the survey. On 05/01/15 at 12:44 pm Patient #21 presented to the Emergency Department (ED) via Emergency Medical System (EMS) escorted by Police. Patient #21 was found to have "Altered Mental Status (AMS), slurred speech and was combative with EMS and a near empty vodka bottle was found in Patients possessions." "Past Medical History: Unknown. Home Medications: Unknown."

At 1:06 pm Haldol (Antipsychotic medication) 5mg IM (Intramuscular) and Ativan (Anti- anxiety medication) 1mg IM was ordered by the physician, Staff Member (SM) #27. SM#29 administered the medication at 1:19 pm at that time he/she documented Patient #21's mental status awake but disoriented. SM#29 documented at 1:33 pm "pt (patient) found ambulating in halls with unsteady gait, pt was escorted back to room with assist, in route pt had a near fall but was assisted by rn {Registered Nurse}, pt returned to stretcher and hooked back up to monitor." At 2:00 pm, SM #29 documented, "pt relocated to front of nursing station in hall a." At 3:38 pm he/she documented, "pt remains in stretcher resting with eyes closed, respirations even and unlabored. At 5:09 pm he/she documented, "pt sat up, asked for some water and then went back to sleep."

On 5/1/15 at 5:57 pm the physician ordered another dose of Haldol 5mg IM and Ativan 1mg IM. SM#29 documented the medication was given at 6:10 pm. At 6:11 pm he/she documented, "pt found ambulating out the ambulance bay, pt was returned to stretcher, pt still has unsteady gait." At 1826 pm he/she documented, "pt resting in stretcher, respirations even and unlabored." At 7:05 pm SM#29 documented, "report given to, care endorsed to SM#30 Rn."

On 5/1/15 at 7:30 pm SM#30 documented, "pt sleeping on stretcher in NAD (no apparent distress) with even nonlabored respirations. Pt in hallway in front of primary RN. Moans to tactile stimuli and returns to sleep." At 9:40 the physician ordered; "Ambulate Hallway." At 9:40 pm the primary nurse documented, "Pt unsteady on her feet not able to ambulate off the stretcher to take 2 steps without falling back onto stretcher with primary RN at bedside." Doctor made aware.

The physician documented the following at 9:28 pm, "pt presented obtunded-smells of etoh (alcohol)-responds to painful stimuli then awoken-verbally abusive to staff-slurred speech-required chemical restraints as patient potential harm to self given high etoh intoxication. Allowed to achieve clinical sobriety. However still very unsteady on [his/her] feet. Will allow to continue to metabolize [his/her] etoh." At 10:46 pm the physician ordered, "Haldol 5mg IM." The primary nurse documented the Haldol was given at 10:53 pm. There were no chemical restraint orders found in the electronic medical record (EMR).

On 07/22/15 at 0910 am a telephone interview was conducted with SM#27. The surveyor asked the physician about the EMR documentation regarding Patient #21. He/she stated they did not want to write an order for chemical restraints it was a miss notation. The physician stated he/she wrote the information during the medical decision making process, but did not want to put the patient in chemical restraints. He/she wanted to keep the patient calm and control their disruptive behavior until clinical sobriety could be achieved. The physician described a chemical restraint as a high dose of an abnormal medication that put someone to sleep.

On 07/22/15 a copy of the hospital policy and procedures titled, "Use of Patient Restraints" with a last update date of 01/13 was reviewed. In the section 'E. Ordering Restraints' the following was noted:
1. Restraint will be ordered by a physician or LIP authorized by the medical staff.
2. PRN {as needed} or standing restraint orders will not be accepted and the ordering practitioner will be contacted to clarify or discontinue the order.
3. The order will specify the method of restraint to be used. (Indications for the restraint will be documented.)
4. The attending physician will be notified as soon as possible if the restraint is not ordered by the patient's attending physician."


2. Patient #59 medical record were reviewed on 07/29/15. On 03/24/15 at 5:45 pm a Non-Behavioral restraint order was written by SM#40, for Soft 2-point (wrist only) restraints. The restraints were not initiated until 03/25/15 at 3:41 pm when SM#41 documented in the Nursing Notes; "Patient is oriented x1. Came back from dialysis and was extremely combative. Restraints initiated as per MD order as patient was pulling at IJ (Intrajugular) line. Rounding very frequently as per restraint protocol. Patient otherwise stable and bed alarm on." SM#41 applied restraints approximately 16 hours after the restraint order was written.
On 07/22/15 a copy of the hospital policy and procedures titled, "Use of Patient Restraints" with a last update date of 01/13 was reviewed. "F. Procedure - Non-Behavioral Restraint Orders [non-violent/protective]
1. If the attending physician is not available, a registered nurse may initiate restraint in advance of a physician's order.
a.) If restraint was necessary due to a significant change in the patient's condition, the attending physician will be contacted immediately for an order.
b.) Otherwise, the attending physician must be notified and a restraint order requested within 4 hours of initiation."

2. The attending physician will perform an in-person assessment of the restrained patient at least once every calendar day, at which time restraint will be either reordered or discontinued as indicated.

On 07/22/15 a copy of the Medical Staff Rules and Regulations was obtained by the surveyors. Under ARTICLE X Titled, "Restraints, Seclusion, and Behavior Management Programs. 10.5. Duration and Renewal of Orders for Restraints or Seclusion:

(b) Non-behavioral Restraints or Seclusion.

If a patient is not violent or self-destructive, the order for restraints may be issued for a period of up to 24 hours, and renewed at the discretion of the attending physician. The attending physician is not required to be physically present to evaluate the need to renew the restraint. Seclusion should not be used if the patient is not violent or self-destructive."

Based on observation, interview, document review and during a complaint investigation it was determined the facility staff failed to ensure orders for physical restraint were not implemented PRN (pro re nata- as needed) for six (6) of twenty-seven (27) restrained patients included in the survey sample. (Patients #32, #52, #59, #62, #64, and #70)

The findings included:

1. Patient #37's electronic medical record (EMR) was reviewed on July 29, 2015 at 10:38 a.m. with Staff #4. Staff #4 navigated Patient #37's EMR. Patient #37's EMR revealed physician's orders for "Behavioral" restraints "4-pt (point) leather" noted at 00:10 a.m. and 3:07 a.m. on January 11, 2015. Staff #4 stated, "We do not have leather restraints anymore, the patient was put in locking vinyl restraints." Nursing documented Patient #37 was in four-point (bilateral wrist and ankle) restraints until 3:06 a.m. on January 11, 2015. Nursing staff documented placing Patient #37 in "2-pt (point)" restraints at 3:06 a.m., until release at 5:05 a.m. on January 11, 2015. Staff #4 verified the physician ordered four point restraints at 3:07 a.m. on January 11, 2015. Staff #4 verified staff failed to obtain a new order for two-point restraints.

2. Patient #62's EMR was reviewed on July 30, 2015 at 10:44 a.m., with Staff #13. Review of Patient #62's EMR revealed a physician's order for bilateral mitts on April 5, 2015 at 9:31 a.m. for pulling at lines. Nursing documentation noted that Patient #62 was placed in restraints at 10:20 a.m. on April 5, 2015. Nursing documentation indicated Patient #62's bilateral mitts were removed at 12:18 p.m. on April 5, 2015. The documentation noted that Patient #62 was placed back in bilateral mitts at 5:00 p.m. on April 5, 2015. Nursing staff did not obtain a new order to apply the bilateral mitt restraints. The original order was implemented as an as needed order.

3. Patient #64's EMR was reviewed on July 30, 2015 at 10:09 a.m., with Staff #13. Patient #64's EMR documented the patient pulled his/her intravenous (IV) line out at 7:51 p.m. and 11:00 p.m. on April 12, 2015. Patient #64 for a third time pulled out his/her IV at 6:30 a.m. on April 13, 2015. Review of physician orders documented an order for restraints, bilateral mitts, at 8:19 a.m. on April 13, 2015 related to the patient "pulling at lines." Nursing documentation on April 13, 2015 at 9:43 a.m. read in part "mitts as needed." Review of nursing and monitoring documentation revealed the first notation of Patient #64 being in bilateral mitts was noted at 8:19 p.m. on April 13, 2015.

Review of the facility's policy titled "Use of Patient Restraints or Seclusion" revised "07/15" read in part "Ordering restraints ... PRN or standing restraint orders will not be accepted and the ordering practitioner will be contacted to clarify or discontinue the order ..."


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4. Patient #52's EMR was reviewed on 07/29/15. On 06/06/15 at 7:01 pm a Non-Behavioral restraint order was written by SM#37, for Soft 2-point (wrist only). The stop date for the order was 06/07/15 at 11:59 pm. According to the Restraint Flow Sheet restraints were applied on 06/06/15 at 7:01 pm. The flow sheet completed by nursing staff every 2 hours showed patient restraint monitoring until 06/07/15 at 11:01 pm, No other documentation noted in the medical record to patient having restraints on until 06/08/15 at 6:59 am. There were no orders for restraints for approximately 19 hours. From 06/07/15 at 11:01 pm to 06/08/15 at 6:59 am there is approximately 8 hours that nursing staff failed to document that patient had restraints in place during this time. The nursing staff restarted Restraint Flow sheet documentation regarding restraints on 06/08/15 at 6:59 am. No renewal order for restraints were found for that time period.
5. Patient #59's EMR was reviewed on 07/29/15. On 03/24/15 at 5:45 pm a Non-Behavioral restraint order was written by SM#40, for Soft 2-point (wrist only). On 03/24/15 at 5:59 pm SM#43 documented "Patient oriented to self only. Refusing all meds and keeps removing O2 (oxygen) mask and pulse ox (oxygen) tape. Refuses to use phone so live interpreter ordered. Family is now at the BS (bedside). Patient is drowsy but order for restraints if needed. Supervisor has been notified as patient has an IJ (Intrajugular) line and pulling could be dangerous. Bed alarm on and VSS (vital signs stable)." On 03/25/15 at 3:41 pm SM#41 documented in the Nursing Notes; "Patient is oriented x 1. Came back from dialysis and was extremely combative. Restraints initiated as per MD order as patient was pulling at IJ (Intrajugular) line. Rounding very frequently as per restraint protocol. Patient otherwise stable and bed alarm on." SM#41 waited approximately 16 hours after the restraint order was written to initiate original restraint order.
6. Patient #70's EMR was reviewed on 07/29/15. On 06/26/15 at 1:47 am a Non-Behavioral restraint order was written by SM#41, for Soft 2-point (wrist only). Restraint orders were renewed every 1 calendar day as per hospital policy until 06/30/15. From 07/01/15 at midnight through 07/16/15 at 9:00 pm nursing staff documented every 2 hours, on the Restraint Flow Sheet, that Patient #70 was in restraints. No Doctor's order for restraints could be found in the medical for this time period. On 07/16/15 at 9:00 pm SM#42 documented, "Bil (bilateral) soft wrist restraints removed at this time and sitter to be at bedside." Patient was restrained for approximately 15.5 days without an order.
On 07/30/15 at 12:25 pm an interview was conducted with the Clinical Information System, Manager. He/she stated, could not find a physician's order for restraints in the medical records form 07/01/16 through 07/16/15.

Based on interview and document review, it was determined the facility staff failed to note the rationale for initiating use of behavioral restraints for two (2) of two (2) patients physically restrained in the emergency department (ED). (Patients #37 and #39)

The findings included:

1. Patient #37's electronic medical record (EMR) was reviewed on July 29, 2015 at 10:38 a.m. with Staff #4. Staff #4 navigated Patient #37's EMR. Patient #37's EMR revealed physician's orders for "Behavioral" restraints "4-pt (point) leather" noted at 00:10 a.m. and 3:07 a.m. on January 11, 2015. The physician's orders did not include the rationale for the behavioral restraints. The section on the order form titled "Reason for Restraint/Seclusion" had been left blank. Staff #4 stated, "We do not have leather restraints anymore, the patient was put in locking vinyl restraints." Nursing documented Patient #37 was in four-point (bilateral wrist and ankle) restraints until 3:06 a.m. on January 11, 2015. Nursing staff documented placing Patient #37 in "2-pt (point)" restraints at 3:06 a.m., until release at 5:05 a.m. on January 11, 2015. Staff #4 verified the physician's orders four point restraints at 11:10 a.m. and 3:07 a.m. on January 11, 2015 failed to include rationale for the use of behavioral restraints. Staff #4 verified staff failed to obtain a new order for two-point restraints.

2. Patient #39's EMR was reviewed on July 29, 2015 at 11:15 a.m., with Staff #4. Patient #39's EMR revealed a physician's order for "Behavioral" restraints "4-pt (point) leather" noted at 2:06 p.m. on June 11, 2015. The physician's orders did not include the rationale for the behavioral restraints. The section on the order form titled "Reason for Restraint/Seclusion" had been left blank. Staff #4 verified the findings and reported the form should have documented the physician's rationale for ordering behavioral restraints.

Review of the facility's policy titled "Use of Patient Restraints or Seclusion" revised "07/15" read in part "Ordering restraints ... The order will specify the method of restraint to be used. (Indications for the restraint will be documented) ..."

An interview was conducted on July 29, 2015 at approximately 9:00 a.m., with Staff #3 regarding the facility's policy on restraints. The surveyor questioned the difference between the restraint policy presented on July 21, 2015, which had a revision date of "01/13" and the policy presented on July 29, 2015 with a revision date of "07/15." Staff #3 reported the surveyor had comment on the new regulations and the facility's leadership group had reviewed and updated their policy. The surveyor noted this regulation had been effective since "10/17/08."

An interview was conducted on July 30, 2015 at approximately 11:00 a.m. with Staff #2, Staff #3, and Staff #7. The facility staff was informed of the findings.

Based on interview, document review and during a complaint investigation, it was determined the facility staff failed to follow the hospital's policy for renewing non-behavioral restraints for four (4) of twenty-three (23) restrained patients included in the survey sample. (Patients #52, #59, #62 and #70)

The findings included:

1. Patient #62's EMR was reviewed on July 30, 2015 at 10:44 a.m., with Staff #13. Review of Patient #62's EMR revealed a physician's order for bilateral mitts on April 5, 2015 at 9:31 a.m. for pulling at lines. Nursing documentation noted that Patient #62 was placed in restraints at 10:20 a.m. on April 5, 2015. Nursing documentation indicated Patient #62's bilateral mitts were removed 12:18 p.m. on April 5, 2015. The documentation noted that Patient #62 was placed back in bilateral mitts at 5:00 p.m. on April 5, 2015. Nursing staff did not obtain a renewal order to reapply the bilateral mitt restraints. Staff #13 verified the findings.


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2. Patient #52 medical records were reviewed on 07/29/15. On 06/06/15 at 7:01 pm a Non-Behavioral restraint order was written by SM#37, for Soft 2-point (wrist only). Nursing documentation showed the restraints were applied at the time the order was written. The order stop date for the restraints was 06/07/15 at 11:59 pm.
The flow sheet completed by nursing staff every 2 hours, showed patient restraint monitoring until 06/07/15 at 11:01 pm. The nursing staff restarted Restraint Flow sheet documentation on 06/08/15 at 6:59 am, after the restraint order had expired. No renewal order for restraints during that time period.
3. Patient #59 medical records were reviewed on 07/29/15. On 03/24/15 at 5:45 pm a Non-Behavioral restraint order was written by SM#40, for Soft 2-point (wrist only). On 03/24/15 at 5:59 pm SM#43 documented "Patient oriented to self only. Refusing all meds and keeps removing O2 {oxygen}mask and pulse ox tape. Refuses to use phone so live interpreter ordered. Family is now at the BS {bedside}. Patient is drowsy but order for restraints if needed. Supervisor has been notified as patient has an IJ {Intrajugular} line and pulling could be dangerous. Bed alarm on and VSS {vital signs stable}." On 03/25/15 at 3:41 pm SM#41 documented in the Nursing Notes; "Patient is oriented x 1. Came back from dialysis and was extremely combative. Restraints initiated as per MD order as patient was pulling at IJ {Intrajugular} line. Rounding very frequently as per restraint protocol. Patient otherwise stable and bed alarm on." SM#41 waited approximately 16 hours after the restraint order was written to initiate original restraint order. No renewal order for restraints were found in the medical record.
4. Patient #70 medical records were reviewed on 07/29/15. On 06/26/15 at 1:47 am a Non-Behavioral restraint order was written by SM#41, for Soft 2-point (wrist only). Restraint orders renewed every 1 calendar day as per hospital policy until 06/30/15. From 07/01/15 at 00:00 am through 07/16/15 at 21:00 pm nursing documented every 2 hours on Restraint Flow Sheet that patient was in restraints. No renewal order for restraints could be found in the medical for this time period. On 07/16/15 at 9:00 pm SM#42 documented, "Bil {bilateral} soft wrist restraints removed at this time and sitter to be at bedside." Patient was restrained for approximately 15.5 days without a restraint order and or a renewal order.
On 07/30/15 at 1225 pm an interview was conducted with the Clinical Information System, Manager. He/she stated, could not find a Doctor's order for restraints in the medical records form 07/01/16 through 07/16/15.
On 07/22/15 a copy of the hospital policy and procedures titled, "Use of Patient Restraints" was reviewed. "F. Procedure - Non-Behavioral Restraint Orders [non-violent/protective]
1. If the attending physician is not available, a registered nurse may initiate restraint in advance of a physician's order.

a.) If restraint was necessary due to a significant change in the patient's condition, the attending physician will be contacted immediately for an order.
b.) Otherwise, the attending physician must be notified and a restraint order requested within 4 hours of initiation."

2. The attending physician will perform an in-person assessment of the restrained patient at least once every calendar day, at which time restraint will be either reordered or discontinued as indicated.

On 07/22/15 a copy of the Medical Staff Rules and Regulations was obtained by the surveyors. Under ARTICLE X Titled, " Restraints, Seclusion, and Behavior Management Programs. 10.5. Duration and Renewal of Orders for Restraints or Seclusion:

(b) Non-behavioral Restraints or Seclusion.

If a patient is not violent or self-destructive, the order for restraints may be issued for a period of up to 24 hours, and renewed at the discretion of the attending physician. The attending physician is not required to be physically present to evaluate the need to renew the restraint. Seclusion should not be used if the patient is not violent or self-destructive."

Based on staff interviews, electronic medical record reviews, facility document reviews and as part of a complaint investigation, it was determined the facility's staff failed to assess and monitor 15 of 27 restraint Patients per hospital policy. (Patients #21, #37, #46, #48, #50, #51, #52, #54, #56, #58, #59, #65, #66, # 67, and #70)
The findings were:
1. Patient #21's medical record was reviewed throughout the survey. On 05/01/15 at 1:06 pm through 10:53 pm, the patient was given three doses of medication(s) as a chemical restraint. No Restraint Flow Sheet was initiated. The required documentation for monitoring patient every 15 minutes and or every 2 hour monitoring and reassessment was not found in the medical record.
2. Patient #66 medical records were reviewed on 07/29/15. On 02/04/15 at 8:15 pm
Behavior restraints were initiated in the Emergency Department (ED). The restraints were in place until 02/05/15 at 1:16 am when 4 Point restraints were removed. No Restraint Flow Sheet initiated. The required documentation for monitoring patient every 15 minutes and or every 2 hour monitoring and reassessment was not found in the medical record.
On 07/21/15 an interview with the ER Patient Care Director (PCD) was conducted. He/she stated that the Restraint Flow Sheet was completed on paper charting and scanned into the medical record. He/she stated that they were unable to find a Restraint Flow Sheet completed on Patient #21 or Patient #66.
On 07/22/15 a copy of the hospital policy and procedures titled, "Use of Patient Restraints" was reviewed. "G. Procedure - Behavioral Restraint (Violent or self-destructive behavior).
I. Ongoing Monitoring

1) A registered nurse will assess the patient at the initiation of restraint.
2) Staff member monitor the patient in restraint and document every 15 minutes on the restraint Status Flow Sheet.
3) Staff will provide 1:1 arms length observation during the restraint episode.
4) Monitoring and reassessment every 2 hours will include the following information, based on the type of restraint employed.

· Level of consciousness
· Circulation to area restrained
· Behavior, Mood, Thoughts
· Physical status
· Orientation
· Vital signs, as ordered
· Nutrition and Hydration & Toileting"

3. Patient #54 medical records were reviewed on 07/29/15. On 01/09/15 at 4:35 am Non-Behavior restraints were initiated in the ED until 2:50 pm when the patient was admitted to the hospital. No Restraint Flow Sheet was initiated. The required every 2 hours monitoring and reassessment documentation was not found in the medical record.
4. Patient #58 medical records were reviewed on 07/29/15. On 02/02/15 at 11:08 am Non-Behavior restraints were initiated in the ED until 3:13 pm when the patient was admitted to the hospital. The staff did not initiate a Restraint Flow Sheet. The required every 2 hours monitoring and reassessment documentation was not found in the medical record.
5. Patient #67 medical records were reviewed on 07/29/15. On 04/11/15 at 2:36 am Non-Behavior restraints were initiated in the ED until 7:10 am when the patient was admitted to the hospital. The required every 2 hours monitoring and reassessment documentation was not found in the medical record.
6. Patient #70 medical records were reviewed on 07/29/15. The medical record documentation stated that on 07/19/15 at 6:11 am that the patient was restrained. The restraints remained in place from 6:11 am to 6:27 pm. No evidence was found that the required every 2 hours monitoring and reassessment documentation was done.
7. Patient #59 medical records were reviewed on 07/29/15. The medical record documentation stated that on 03/25/15 at 1:44 pm the patient was restrained. From 1:44 pm to 7:44 pm the required every 2 hours monitoring and reassessment documentation was not found in the medical record.
8. Patient #56 medical records were reviewed on 07/29/15. The medical record documentation stated that on 01/28/15 at 7:25 am the patient was restrained. The patient remained in restraints from 7:25 am to 1:00 pm with no evidence of monitoring or reassessment.
9. Patient #52 medical records were reviewed on 07/29/15. The medical record documentation noted restraints were initiated on 6/7/15 at 11:01pm. Patient #52 remained in restraints from 06/07/15 a 11:01 pm through 06/08/15 at 6:59 am without evidence of monitoring or reassessment.



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10. Patient #37's electronic medical record (EMR) was reviewed on July 29, 2015 at 10:38 a.m. with Staff #4. Staff #4 navigated Patient #37's EMR. Patient #37's EMR revealed physician's orders for "Behavioral" restraints "4-pt (point) leather" noted at 00:10 a.m. and 3:07 a.m. on January 11, 2015. Staff #4 stated, "We do not have leather restraints anymore, the patient was put in locking vinyl restraints." Nursing documented Patient #37 was in four-point (bilateral wrist and ankle) restraints until 3:06 a.m. on January 11, 2015. Patient #37's flowsheet for every 15 minutes checks contained a forty-one (41) minute gap. Staff #4 reviewed Patient #37's EMR in order to determine if the patient had left the unit for test or procedures. Staff #4 reported Patient #37's EMR did not indicate the patient was off the unit. Staff #4 verified staff had failed to document the performance of required monitoring between 2:25 a.m. and 3:06 a.m. January 11, 2015.

11. Review of Patient #46's EMR was conducted on July 29, 2015 at 5:45 p.m., with Staff #13. Patient #48's EMR included a physician's order dated June 29, 2015 at 11:59 p.m. for non-behavioral restraints bilateral "Mitts- pulling at lines." The review revealed the the restraint monitoring flowsheet stopped at "05:55 (a.m.)" on June 30.2015 Review of nursing documentation for June 30, 2015 at "10:50 (a.m.)" read in part: "...mitten restraints bilat (bilaterally)." Staff #13 verified the monitoring stopped at 5:55 a.m. on June 30, 2015, the nursing documentation noted the patient was still in mitten restraint at 10:50 a.m. on June 30, 2015.

12. Review of Patient # 48's EMR was conducted on July 29, 2015 at 6:10 p.m., with Staff #13. Review of Patient #48's EMR revealed an physician's order for bilateral mitts dated July 17, 2015 and timed at 1:00 a.m. to restrain the patient from "pulling out lines." Review of the nursing documentation for July 17, 2015 at "09:36 (a.m.)" read in part: "Pt (Patient) frequently pulling at peripheral IV (intravenous) site overnight, despite redirection by staff/family. MD (medical doctor) consulted, order placed for mitten restraints. Mittens too large to remain in place (pt's hands very small) so socks placed over pt's hand, extended up to elbow with good effect ..." Review of Patient #48's EMR did not reveal staff had performed the every two hour monitoring for non-behavioral restraints. Staff #13 verified Patient #48 had a revised plan of care that reflected he/she had been placed in restraints. Staff #13 verified Patient #48's EMR did not have restraint monitoring.

13. Review of Patient #50's EMR was conducted on July 29, 201 at 8:49 a.m., with Staff #46. Patient #51's EMR indicated he/she was 56 years old. Patient #50's EMR documented the patient was placed in seclusion on May 31, 2015 at "00:49 (a.m.)." Nursing documentation for May 31, 2015 indicated the nurse had attempted to explain "condition locked seclusion to be discontinued." The nurse's note documented Patient #50 was not receptive to the information and "continued to bang on seclusion door." Review of Patient #50's "24 Hour Patient Safety Monitoring" flowsheet for this time frame documented the patient was "calm in the quiet room." Staff #46 stated, "If the quiet room's room is locked it becomes seclusion." Staff #46 verified if Patient #50 was banging on the seclusion room door the patient was not quiet. Staff #46 verified Patient #50's "24 Hour Patient Safety Monitoring" flowsheet did not have the every 15-minute checks required for a patient in seclusion. Staff #46 reported the code used by the staff related to the patient's location was not correct.

14. Review of Patient #51's EMR was conducted on July 29, 201 at 9:23 a.m., with Staff #46. Patient #51's EMR indicated he/she was 19 years old. Patient #51 had four orders for seclusion: January 30, 2015 at "13:06 [1:06 p.m.] Discontinued time", January 30, 2015 at "15:33 (3:33 p. m.) Discontinued time", January 30, 2015 at "16:48 (4:48 p.m.) Discontinued time", and January 31, 2015 at "10:49 (a.m.) Discontinued time." Staff #46 reported only the "Discontinued time" was visible when the chart was closed. Review of the January 30, 2015 at "15:36 (3:36 p.m.)" nurse's noted Patient #52 had been in seclusion twice. Review of "24 Hour Patient Safety Monitoring" flowsheets for January 30 and 31, 2015 did not indicate Patient #51 had been in seclusion. Patient #51's "24 Hour Patient Safety Monitoring" flowsheets did not have the required 15-minute checks for behavioral restraint/seclusion. Staff #46 verified facility staff had failed to monitor Patient #51 as required for seclusion.

15. Review of Patient #65's EMR was conducted on July 30, 2015 at 9:37 a.m., with Staff #13. Patient #65's EMR documented the patient was admitted to the facility on April 27, 2015. Patient #65's EMR documented a physician's order to place the patient in bilateral mitts to keep him/her from "pulling on lines" at 3:51 p.m. on April 29, 2015. Review of nursing documentation read in part: "04/29/15 1551 (3:51 p.m.) ... resting in bed with mittens" and "04/30/15 0437 (4:37 a.m.) ...has mittens on as ordered." Staff #13 and the surveyor reviewed Patient #65's EMR for documentation of monitoring the patient while in restraints. Staff #13 verified Patient #65's EMR did not have restraint flowsheets. Staff #13 verified Patient #65's EMR did not contain evidence the patient had been assessed while in restraints.

Review of the facility's policy titled "Use of Patient Restraints or Seclusion" revised "07/15" read in part "F. Procedure- Non-Behavioral Restraint Orders [non-violent/protective] .... F. Non-Behavioral Restraint Monitoring and Documentation ... d. Monitoring will occur no less than every 2 hours and will include: Level of consciousness, circulation to Area restrained, Behavior, Mood, Thoughts, Physical status, Orientation, Vital signs as appropriate, Nutrition, Hydration and toileting, and Readiness for Discontinuation of Restraint ... G. Procedure - Behavioral Restraint(Violent or self destructive behavior) or Seclusion [sic] ... j. Ongoing Monitoring ... 2. Staff members monitor the patient in restraints and document every 15 minutes on the restraint Status Flow Sheet ..."

Based on staff interviews, electronic medical record reviews, facility document reviews and as part of a complaint investigation, it was determined the facility's staff failed to document patient behavior prior to using restraints for one (1) of twenty-seven (27) restrained patients included in the survey sample. (Patient #67)
The findings were:
Patient #67's medical record was reviewed on 07/29/15. On 04/11/15 at 2:28 am Staff Member (SM)#38 documented, "PT (Patient) family requesting restraints, MD aware." At 2:36 am SM#38 noted that Patient #67 was placed in 4 point soft restraints per a physician order. On 04/11/15 at 2:30 am SM#45 wrote an order for Non-Behavior 4 point restraints. No documentation was found in the medical record regarding the patient's need for restraint other than the family's request for restraints.
On 07/29/15 at 9:00 am an interview was conducted with the ER Patient Care Director. He/she stated a reason for the restraint, other than family request, should have been documented by the nurse and or physician. The Director stated it was not the hospital's practice to place a patient in restraints due only to a family request.
On 07/22/15 a copy of the hospital policy and procedures titled, "Use of Patient Restraints" with a last update date of 01/13 was reviewed. "F. Procedure - Non-Behavioral Restraint Orders [non-violent/protective].
3. Non-behavioral Restraint Monitoring and Documentation:

a. Type and location of the restraining devices(s) will be documented at least once per shift and when changed.
b. Rational for restraint (observed condition or behavior) will be assessed on an ongoing basis and documented.
c. Alternatives to the less restrictive forms of restraint considered by the care giver will be documented.
d. Monitoring will occur no less than every 2 hours and will include: Level of Consciousness, Circulation to Area Restrained, Behavior, Mood, Thoughts, Physical status, Orientation, Vital signs as appropriate, Nutrition, Hydration and toileting, and Readiness for Discontinuation of Restraint.
e. Consultations."

On 07/22/15 a copy of the Medical Staff Rules and Regulations was obtained by the surveyors. Under ARTICLE X "Titled, Restraints, Seclusion, and Behavior Management Programs. 10.6. Documentation:

When restraint or seclusion is used, there must be documentation in the patient's medical record of the following:

(b) a description of the patient's behavior and the intervention used;"

Based on interview, document review, and during a complaint investigation it was determined the facility staff failed to provide discharge plans, which included adequate pain control for one (1) of thirty (30) patients included in the survey sample that received emergency medical stabilizing treatment. (Patient #25)

The findings included:

Review of Patient #25's electronic medical record (EMR) documented the patient arrived via emergency medical transport on May 2, 2015 after a motorcycle accident. Patient #25's EMR documented the patient arrived at 7:48 p.m., was triaged for acuity at 7:57 p.m., and was seen by a physician by 8:12 p.m. on May 2, 2015. Patient #25's EMR documented laboratory and radiological studies were performed as part of the patient's medical screening examination. Patient #25's EMR included evidence of a consultation by the on-call orthopedist (Staff #32) related to the patient's fractures including the closed reduction of the right wrist fracture, splinting, and follow-up visit. Patient #25's EMR documented at 00:06 a.m. on May 3, 2015 the patient's pain level was documented as "0 [no pain]. Patient #25's EMR documented the patient was discharged at "01:56 [1:56 a.m.]" on May 3, 2015. The facility staff failed to document the patient's level of pain at discharge. Review of Patient #25's "Discharge - Home Instructions" read in part "your prescriptions were called into [name of a local pharmacy chain and their address]. Percocet/zofran/miralax."

[According to www.drugs.com:
"Percocet contains a combination of acetaminophen and oxycodone. Oxycodone is an opioid pain medication. An opioid is sometimes called a narcotic. Percocet is a narcotic pain reliever used to treat moderate to severe acute pain ... It is regulated as a schedule II medication by the Drug Enforcement Agency of the United States."

"Zofran (ondansetron) blocks the actions of chemicals in the body that can trigger nausea and vomiting. Zofran is used to prevent nausea and vomiting that may be caused by surgery or by medicine to treat cancer ..."

"MiraLax (polyethylene glycol 3350) is a laxative solution that increases the amount of water in the intestinal tract to stimulate bowel movements. MiraLax is used as a laxative to treat occasional constipation or irregular bowel movements ..."]

A telephone interview was conducted on July 22, 2015 at 8:15 a.m., with Patient #25 and [his/her] spouse. Patient #25 deferred to his/her spouse to answer questions related to the patient's discharge and instructions. Patient #25's spouse reported when they arrived at the pharmacy they were not able to obtain the pain medication. Patient #25's spouse stated, "We had to wait until the pharmacy contacted the physician in the emergency department. A different medication was prescribed that did not work as well." Patient #25's spouse reported the patient was in pain until they went to a different hospital's ED on Monday May 4, 2015.

A telephone interview was conducted on July 22, 2015 at approximately 9:09 a.m., with Staff #27. Staff #27 reported being familiar with Patient #25's May 2, 2015 emergency department (ED) visit. Staff #27 stated, "I was trying to help the family they requested I call in the prescriptions." Staff #27 reported the patient had not been given a hard copy for the Percocet prescription. Staff #27 stated, "I forgot Schedule II narcotics should not be called into a pharmacy. The pharmacy called and we were able to order something else for [his/her] pain."

A telephone interview was conducted on July 22, 2015 at 2:01 p.m., with Staff #44. Staff #44 reported familiarity with Patient #25's case related to the facility's investigation of a complaint filed by Patient #25. Staff #44 reported Patient #25's EMR documented the eventual need for surgery for the right wrist once the swelling had subsided and Patient #25 had been given a follow-up appointment to see a wrist specialist within forty-eight (48) hours. Staff #44 stated, "There was no clear reason for hospitalization. The ongoing issues would be pain control, with a strong pain medication for home use." Staff #44 identified a flaw in Patient #25's discharge planning; "We do not telephone any medication order to pharmacy, just not our practice in the ED. [Staff #27's name] forgot Schedule II medication, Percocet, could not be phoned in."