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Based on the systemic nature of the standard-level deficiencies related to patient rights, the facility staff failed to substantially comply with this condition. This includes a citation of Immediate Jeopardy (IJ) related to the facility's ordering, evaluating, and monitoring patients in violent (behavioral) restraints under §482.13(e)(4)(ii), §482.13(e)(8), §482.13(e)(12), as well as the lack of evidence of physician/LIP (licensed independent practitioner) training for restraint use under §482.13(e)(11).

On 3/4/15 at 2:10 p.m. the survey team met with the facility's chief operating officer/chief nursing officer, director of clinical effectiveness, and accreditation manager. They were informed that the failure to order, renew orders, evaluate and appropriately monitor patients in restraints applied in part due to patients violent and/or aggressive behaviors, as well as a lack of a policy requiring training on restraints for physicians and/or licensed independent practitioners indicated a finding of an Immediate Jeopardy deficiency.

On 3/4/15 at 4:05 p.m., the survey team was provided a written Plan of Correction dated 3/4/15 which detailed the facility staff's immediate plan to address the survey team's findings related to their restraint policy changes, educating emergency department physicians, hospitalists, and advanced clinical practitioners and monitoring for compliance with restraint policy. A copy of the facility's new "draft" version of the "Restraints, Use of" policy was provided along with evidence that the providers working on 3/4/15, one ED physician and one Physician Assistant, had completed restraint competency on 3/4/15. The Immediate Jeopardy was removed during the survey when the facility provided an accepted Plan of Correction for the IJ.

The facility's Plan of Correction included 4 topics: "1) A Memo outlining policy changes to align our current policy with CMS Conditions of Participation will be sent to each unit by 4:00 pm today, March 4th. All staff will be asked to review policy and sign acknowledging their understanding of new requirements. The Draft Restraint Policy will be presented to Medical Staff Executive Committee for discussion and approval on March 10th. The policy will then be presented to the full Medical Staff following the MEC meeting. Following policy approval, education about policy changes will occur for all providers and staff. This will be completed by March 24th. 2) A proposal to the Medical Staff will be made to amend the Medical Staff Rules and Regulations to include the following requirement: It will [sic] the responsibility of the Emergency Department physician, Hospitalist and/or Advanced Clinical Practitioner to understand and abide by (facility's name) Restraint Policy including but not limited to completing Cornerstone education upon hire and annually thereafter. Prior to providing patient care, competency validation for restraint use will also be required. For new providers, a quality review of the provider's restraint order documentation will occur for the first three cases to ensure appropriate and accurate documentation. This proposal will be presented to the Medical Staff Executive Committee and full Medical Staff on March 10th. For new providers, this same information will be provided as part of their Orientation Packet. The new provider packet will be amended and available April 1, 2015. 3) All providers will complete the (name of education program) Education and competency validation prior to providing patient care. In addition, a review of appropriate restraint order documentation in (name of computer system) will be provided. For ED/Hospitalist and PA on duty March 4th, this will be completed by 4:00pm today. For providers reporting for duty, this will be completed prior to assuming care of patients, each shift until all providers have completed. 4) For the next six months (March 5 - August 5) and as a continuous quality indicator, documentation related to the use of restraints will be reviewed. The Lead Nurse in the ED and the Charge Nurse on Med Surg will review the patient's chart for appropriate orders and documentation related to restraint use. The Quality Facilitator will also review all restraint charts for the same sixty days. The results of these audits will be shared with leadership at monthly Safety and Quality committee meetings."

Based on staff interviews, electronic medical record reviews, facility document review, and as part of a complaint investigation, it was determined the facility's staff failed to 1) implement violent or self-destructive behavioral restraints according to facility policy for 2 of 2 sampled patients who had documented restraint use (Patient #2 and Patient #5). Patient #2 and Patient #5 were the only patients documented to have had restraints applied during a three month period; both Patient #2 and Patient #5 had bilateral wrist and bilateral ankle restraints applied. 2) The facility staff failed to ensure a verbal order was authenticated within 72 hours according to State law for 1 of 2 verbal orders for Patient #2.

The findings were:

A. Patient #2's medical record was reviewed throughout the survey. The initial restraint order was a verbal order written with telephone readback by a registered nurse (RN) on 1/10/15 at 1921. The order was authenticated by a physician assistant (PA #1) 31 minutes later. The restraint type was documented as "NON-VIOLENT Ankle restraints" and "NON-VIOLENT Wrist restraints." The reason for restraint was documented as "Pulling at medical equipment" and the order duration was for "24 hours." A renewal order was documented as a verbal order written with verbal readback by a licensed practical nurse (LPN) on 1/11/15 at 1857 (6:57 p.m.) and authenticated by PA#1 on 1/16/15 at 1837 (6:367 p.m.), over 119 hours following the verbal order. The order included the restraint type as "NON-VIOLENT Wrist restraints" and "NON-VIOLENT Ankle restraints" with the reason for restraint documented as "Pulling at medical equipment" and "Picking at tape, dressings, or other medical equipment." There were no other restraint orders found in the medical record.

Patient #2's medical record documented restraint monitoring every 2 hrs beginning on 1/10/15 at 1900 (7:00 p.m.) and discontinued on 1/12/15 at 0000 (midnight) when the patient was discharged. Progress Notes documented:
a) 1/10/15 at 6:15 p.m. - "Staring into the air reaching for things that are not there, hitting hands on bedrails, kicking feet into side of bed, grabbed cathter [sic] and pulled tubing nearly apart, hitting at staff. Talks in complete sentences at will then grunts and moans at other times. (Physician's name) notified of agitation, new orders noted."
b) 1/10/15 at 7:30 p.m. - "... Patient is in bed, restrained. Remains agitated. Pulling on foley, monitor leads and other equipment. Attempting to hit staff and spit on staff. Unable to calm. Patient unable to follow commands. Will medicate and ordered [sic] and monitor for effectiveness. Unable to complete assessment or obtain vital signs at this time. Will complete when patient calmer."
c) 1/10/15 at 7:35 p.m. - "(Patient's child) called requesting to speak to patient. Patient agitated, pulling on restraints. Unable to cooperate with staff. Informed (patient's child) that patient and staff unable to talk to (him/her) at this time. (He/She) should call back later."
d) 1/11/15 at 7:26 a.m. - "(Patient) calm at this time, no distress noted. (Patient) remains in restraints. Report received from previous shift. Assessment completed, see doc flow sheets. (Patient) was restless when this nurse did assessment, however, (he/she) is calm at this time. (Patient) remains 1:1 observation. Will continue to monitor."
e) 1/11/15 at 4:20 p.m. - "(Patient) still appears to be sleeping. When (he/she) does wake up (he/she) is still grunting and trying to pull at catheter and IV tubing despite (he/she) restraints. Will continue to monitor."
f) 1/11/15 at 6:59 p.m. stated, "...(Patient) still combative at times, asleep most of shift. No distress noted..."

Patient #2's clinical documentation included evidence of suicide precaution checks every 15 minutes during the time the restraints were applied; these every 15 minute checks did not include documentation of respirations or other vital signs (pulse and blood pressure), comfort assessment, and/or physical and psychological status assessment.

Patient #2's discharge summary completed by Physician Assistant (PA) #1 on 1/11/15 at 5:23 p.m. and cosigned by Physician #1 on 1/19/15 at 9:42 a.m. included the following information:
- "Patient continues to only grunt and make occasional demands - moving all extremities remains agitated and aggressive. "
- "Constitutional: (vital signs stable). Patient is responsive to pain, noxious stimulus, and will request things at (his/her) leisure - otherwise aggressive and grunting. Remains in 4 point restraints due to aggressive behavior."

Patient #2's clinical record included a section entitled 'Care Plan.' Under the 'Care Plan' section the following information was found: "Problem: Restraint Use (Adult, OB, Pediatrics)" with a start date of 1/10/15. Under the "Problem: Restraint Use (Adult, OB, Pediatrics)" were 'interventions' which include the two following: (a) Intervention: Enhance behavior management - Dates: Start: 01/10/15 - Frequency: AS NEEDED - Description: Violent/Self Destructive, Aka [sic] Behavior Health Restraint USE ONLY [sic] and (b) Intervention: Provide debriefing (violent/self destructive only) - Dates: Start: 01/10/15 - Frequency: AS NEEDED - Description: Violent/Self Destructive. The aforementioned care plan included a 'frequency' of 'as needed' but the physician assistant order was not written as an 'as needed' order.

During an interview with Physician Assistant (PA) #1 on 3/3/15 at 1:40 p.m., PA #1 stated Patient #2's bilateral wrist and bilateral ankle restraints were due to the patient being combative, aggressive, and punching staff.

During an interview with Physician #1 on 3/3/15 at 4:00 p.m., Physician #1 was asked about the reason, violent or nonviolent, for Patient #2's restraint order that he/she had cosigned. After discussing Patient #2's presentation/situation at the time of the restraint order, Physician #1 stated, "If punching I guess it would be violent."

B. Patient #5's medical record was reviewed in the morning of 3/4/15. The initial restraint order was a verbal order taken with verbal readback by a registered nurse on 1/8/15 at 1723. The verbal order was authenticated by one of the facility's physician assistants 58 minutes later. The restraint type was documented as "NON-VIOLENT Wrist restraints" and "NON-VIOLENT Ankle restraints." The Reason for Restraint was documented as "Severe cognition impairment (Enclosure bed only)" with a duration of "24 hours." In an interview with the emergency department manager in the afternoon on 3/4/15, he/she said the facility did not have enclosure beds so that documentation was an incorrect entry into the electronic record. There were no other restraint orders found in the medical record.

Patient #5's medical record documented restraint monitoring every 2 hours from 1/8/15 at 1715 (5:15 p.m.) through 1/9/15 at 1300 (1:00 p.m.). Progress notes related to restraints/behavior documented:
- on 1/8/15 at 2:30 p.m. - "(Patient) appears to be slightly anxious at this time, however, CIWA (Clinical Institution Withdrawal Assessment) score is only 4 at this time. (Patient) refused medications at this time. Will continue to monitor."
- on 1/8/15 at 2:55 p.m. - "(Patient) trying to pull out foley catheter at this time. Ativan 1 mg given at this time per order of (Physician Assistant). CIWA score is 23 at this time. Foley catheter is removed at this time, pt tolerated well. Will continue to monitor."
- on 1/8/15 at 3:27 p.m. - "(Patient) sitting up in chair at this time states that (he/she) feels better. Will continue to monitor."
- on 1/8/15 at 4:10 p.m. - "Walked into (patient's) room, (patient) has spilled an entire pitcher of ice water on floor and pulled out (his/her) 18 gauge IV. (Physician Assistant) informed. Ativan 2 mg IV given at this time, CIWA score 27. Will continue to monitor."
- on 1/8/15 at 4:45 p.m. - "(Patient's) family present at this time. Attempting to convince (patient) to stay, (patient) refusing, wanting to sign out AMA. (Patient) unsteady on feet and pulling at IV lines. (Physician Assistant) notified."
- on 1/8/15 at 5:15 p.m. - "(Patient) placed in four point soft restraints at this time per order of (Physician Assistant) due to pt pulling at IV lines and foley catheter. Ativan 2 mg IV given at 1710 for agitation, CIWA score 33. Will continue to monitor."
- on 1/8/15 at 6:14 p.m. - "(Patient) becoming very confused and combative as the evening progressed. Hallucinating. Tremor. Full active DTs. Contacted family and discussed POC. (Patient) restrained for safety - medicated per CIAWA [sic] protocol - continue treatment per pathway. Notified and discussed with (physician). Likely 2-3 more days."
- on 1/8/15 at 6:48 p.m. - "End of shift note. (Patient) still sedated, resting quietly, four point restraints intact. Will report to oncoming shift."
- on 1/9/15 at 2:18 a.m. - "Inserted foley catheter."

The facility's policy/procedure titled, "Restraints, Use of " with a last updated date of 10-2014 was reviewed on 3/3/15 and 3/4/15. Under "Implementation of Restraints," the procedure separated the information into two columns, one titled, "Non-Violent Restraints" and the second titled, "Violent Use Restraints." For Violent Use Restraints, the procedure documented:
"Use of Restraints - Emergency situations where behavior is dangerous, violent, or aggressive. Also used to protect the patient from injury to self or others. Applicable regardless of patient care settings.
Initial Order - LIP, NP, or PA must see and evaluate patient within one (1) hour of initiation of restraints for behavioral health purposes. Order limited to four (4) hours for adults, two (2) hours for children 9-17 years of age, and one (1) hour for children less than 9 years of age.
Continued Use of Restraints - If restraint for behavioral health purposes needs to be continued beyond the expiration of the time limited order, a new order is obtained.
Patient Evaluation for Continued Use of Restraints - In person re-evaluation by LIP completed at least:
Every 8 hours for patients ages 18 and older
every 4 hours for ages 9-17
every 2 hours for patients under 9
Monitoring of Patients - The patient is assessed every 15 minutes for the following:
- Vital signs (at a minimum respirations are assessed)
- Hygiene and elimination
- Physical and psychological status and comfort
Discontinuation of Restraints - Discontinue when patient meets behavior criteria. Inform patient as soon as possible of the rationale for use and criteria to discontinue. Staff assist the patient to meet criteria for discontinuation. Following a comprehensive assessment, intervention, evaluation and re-intervention by an RN, restraints may be removed. Patient debriefing is required as soon as possible after restraint is removed and is documented. Debriefing occurs as soon as possible, but no longer than 24 hours, after each episode and documented in the medical record.
PRN Orders - No."

The procedure listed under, "Orders for Restraints/Protective Interventions" in part, "5. The ordering physician must authenticate verbal orders within time stated in Medical Staff Bylaws for Acute Care." The Rules and Regulations of the Medical Staff dated May 2013 was reviewed on 3/3/15 and listed in part, "3.2 ... These verbal orders must be authenticated by the responsible practitioner, as required by state or federal law and regulations." In an interview with the facility's director of clinical effectiveness on 3/3/15 at 11:45 a.m., he/she acknowledged verbal orders were to be authenticated no longer than 72 hours after the verbal order was given. He/she also acknowledged the timeframes listed under "Patient Evaluation For Continued Use of Restraints" did not reflect the timeframes required by §482.13(e)(8).

Based on staff interviews, electronic medical record review, facility document review, and during the course of a complaint investigation it was determined the facility staff failed to renew restraint orders for the management of violent or self-destructive behavior every 4 hours for 2 of 2 patients who had been placed in restraints in a three (3) month period. (Patient #2 and Patient #5). Both patients had 2 point wrist and 2 point ankle restraints ordered and both patients were over 18 years old.

The findings were:

1. Patient #2's electronic medical record was reviewed throughout the survey. The initial restraint order was a verbal order written with telephone readback by a registered nurse (RN) on 1/10/15 at 1921 (7:21 p.m.). The restraint type was documented as "NON-VIOLENT Ankle restraints" and "NON-VIOLENT Wrist restraints." The reason for restraint was documented as "Pulling at medical equipment" and the order duration was for "24 hours." A renewal order was documented as a verbal order written with verbal readback by a licensed practical nurse (LPN) on 1/11/15 at 1857 (6:57 p.m.), over 23 hours after the initial restraint order. The order included the restraint type as "NON-VIOLENT Wrist restraints" and "NON-VIOLENT Ankle restraints" with the reason for restraint documented as "Pulling at medical equipment" and "Picking at tape, dressings, or other medical equipment." There were no other restraint orders found in the electronic medical record therefore, while Patient #2 had bilateral wrist and ankle restraints for violent or self-destructive behavior (see information below) for approximately 28 hours, there were 2 restraint orders, almost 24 hours apart.

Patient #2's electronic medical record documented restraint monitoring every 2 hrs beginning on 1/10/15 at 1900 (7:00 p.m.) and discontinued on 1/12/15 at 0000 (midnight) when the patient was discharged. Progress Notes documented:
a) 1/10/15 at 6:15 p.m. - "Staring into the air reaching for things that are not there, hitting hands on bedrails, kicking feet into side of bed, grabbed catheter [sic] and pulled tubing nearly apart, hitting at staff. Talks in complete sentences at will then grunts and moans at other times. (Physician's name) notified of agitation, new orders noted."
b) 1/10/15 at 7:30 p.m. - "... Patient is in bed, restrained. Remains agitated. Pulling on foley, monitor leads and other equipment. Attempting to hit staff and spit on staff. Unable to calm. Patient unable to follow commands. Will medicate and ordered [sic] and monitor for effectiveness. Unable to complete assessment or obtain vital signs at this time. Will complete when patient calmer."
c) 1/10/15 at 7:35 p.m. - "(Patient's child) called requesting to speak to patient. Patient agitated, pulling on restraints. Unable to cooperate with staff. Informed (patient's child) that patient and staff unable to talk to (him/her) at this time. (He/She should call back later."
d) 1/11/15 at 7:26 a.m. - "(Patient) calm at this time, no distress noted. (Patient) remains in restraints. Report received from previous shift. Assessment completed, see doc [sic] flow sheets. (Patient) was restless when this nurse did assessment, however, (he/she) is calm at this time. (Patient) remains 1:1 observation. Will continue to monitor."
e) 1/11/15 at 4:20 p.m. - "(Patient) still appears to be sleeping. When (he/she) does wake up (he/she) is still grunting and trying to pull at catheter and IV tubing despite (he/she) restraints. Will continue to monitor."
f) 1/11/15 at 6:59 p.m. stated, "...(Patient) still combative at times, asleep most of shift. No distress noted..."

Patient #2's discharge summary completed by Physician Assistant (PA) #1 on 1/11/15 at 5:23 p.m. and cosigned by Physician #1 on 1/19/15 at 9:42 a.m. included the following information:
- "Patient continues to only grunt and make occasional demands - moving all extremities remains agitated and aggressive."
- "Constitutional: (vital signs stable). Patient is responsive to pain, noxious stimulus, and will request things at (his/her) leisure - otherwise aggressive and grunting. Remains in 4 point restraints due to aggressive behavior."

Patient #2's electronic medical record included a section entitled 'Care Plan.' Under the 'Care Plan' section the following information was found: "Problem: Restraint Use (Adult, OB, Pediatrics)" with a start date of 1/10/15. Under the "Problem: Restraint Use (Adult, OB, Pediatrics)" were 'interventions' which include the two following: (a) Intervention: Enhance behavior management - Dates: Start: 01/10/15 - Frequency: AS NEEDED - Description: Violent/Self Destructive, Aka [sic] Behavior Health Restraint USE ONLY [sic] and (b) Intervention: Provide debriefing (violent/self destructive only) - Dates: Start: 01/10/15 - Frequency: AS NEEDED - Description: Violent/Self Destructive. The aforementioned care plan included a 'frequency' of 'as need' but the physician assistant order (cosigned by a physician) was not written as an 'as needed' order.

During an interview with Physician Assistant (PA) #1 on 3/3/15 at 1:40 p.m., PA #1 stated Patient #2's bilateral wrist and bilateral ankle restraints were due to the patient being combative, aggressive, and punching staff.

During an interview with Physician #1 on 3/3/15 at 4:00 p.m., Physician #1 was asked about the reason, violent or nonviolent, for Patient #2's restraint order that he/she had cosigned. After discussing Patient #2's presentation/situation at the time of the restraint order, Physician #1 stated, "If punching I guess it would be violent."

2. Patient #5's electronic medical record was reviewed in the morning of 3/4/15. The initial restraint order was a verbal order taken with verbal readback by a registered nurse on 1/8/15 at 1723 (5:23 p.m.). The restraint type was documented as "NON-VIOLENT Wrist restraints" and "NON-VIOLENT Ankle restraints." The Reason for Restraint was documented as "Severe cognition impairment (Enclosure bed only)" with a duration of "24 hours." In an interview with the emergency department manager in the afternoon on 3/4/15, he/she said the facility did not have enclosure beds so that documentation was an incorrect entry into the electronic record. There were no more restraint orders found in the electronic medical record therefore, while Patient #5 was monitored for bilateral wrist and ankle restraints due to violent, possibly self-destructive behavior (see information below) for approximately 20 hours, there was one restraint order.

Patient #5's electronic medical record documented restraint monitoring every 2 hours from 1/8/15 at 1715 (5:15 p.m.) through 1/9/15 at 1300 (1:00 p.m.). Nursing progress notes related to restraints/behavior documented:
- on 1/8/15 at 2:30 p.m. - "(Patient) appears to be slightly anxious at this time, however, CIWA (Clinical Institution Withdrawal Assessment) score is only 4 at this time. (Patient) refused medications at this time. Will continue to monitor."
- on 1/8/15 at 2:55 p.m. - "(Patient) trying to pull out foley catheter at this time. Ativan 1mg given at this time per order of (Physician Assistant). CIWA score is 23 at this time. Foley catheter is removed at this time, (patient) tolerated well. Will continue to monitor."
- on 1/8/15 at 3:27 p.m. - "(Patient) sitting up in chair at this time states that (he/she) feels better. Will continue to monitor."
- on 1/8/15 at 4:10 p.m. - "Walked into (patient's) room, (patient) has spilled an entire pitcher of ice water on floor and pulled out (his/her) 18 gauge IV. (Physician Assistant) informed. Ativan 2 mg IV given at this time, CIWA score 27. Will continue to monitor."
- on 1/8/15 at 4:45 p.m. - "(Patient's) family present at this time. Attempting to convince (patient) to stay, pt refusing, wanting to sign out AMA. (Patient) unsteady on feet and pulling at IV lines. (Physician Assistant) notified."
- on 1/8/15 at 5:15 p.m. - "(Patient) placed in four point soft restraints at this time per order of (Physician Assistant) due to (patient) pulling at IV lines and foley catheter. Ativan 2 mg IV given at 1710 for agitation, CIWA score 33. Will continue to monitor."
- on 1/8/15 at 6:14 p.m. - "(Patient) becoming very confused and combative as the evening progressed. Hallucinating. Tremor. Full active DTs. Contacted family and discussed POC. (Patient) restrained for safety - medicated per CIAWA [sic] protocol - continue treatment per pathway. Notified and discussed with (physician). Likely 2-3 more days."
- on 1/8/15 at 6:48 p.m. - "End of shift note. (Patient) still sedated, resting quietly, four point restraints intact. Will report to oncoming shift."
- on 1/9/15 at 2:18 a.m. - "Inserted foley catheter."

The facility's policy/procedure titled, "Restraints, Use of " with a last updated date of 10-2014 was reviewed on 3/3/15 and 3/4/15. Under "Implementation of Restraints," the procedure separated the information into two columns, one titled, "Non-Violent Restraints" and the second titled, "Violent Use Restraints." For Violent Use Restraints, the procedure documented: "Use of Restraints - Emergency situations where behavior is dangerous, violent, or aggressive. Also used to protect the patient from injury to self or others. Applicable regardless of patient care settings. Initial Order - LIP, NP, or PA must see and evaluate patient within one (1) hour of initiation of restraints for behavioral health purposes. Order limited to four (4) hours for adults, two (2) hours for children 9-17 years of age, and one (1) hour for children less than 9 years of age. Continued Use of Restraints - If restraint for behavioral health purposes needs to be continued beyond the expiration of the time limited order, a new order is obtained.

Patient Evaluation for Continued Use of Restraints - In person re-evaluation by LIP completed at least:
Every 8 hours for patients ages 18 and older
every 4 hours for ages 9-17
every 2 hours for patients under 9
Monitoring of Patients - The patient is assessed every 15 minutes for the following:
- Vital signs (at a minimum respirations are assessed)
- Hygiene and elimination
- Physical and psychological status and comfort
Discontinuation of Restraints - Discontinue when patient meets behavior criteria. Inform patient as soon as possible of the rationale for use and criteria to discontinue. Staff assist the patient to meet criteria for discontinuation. Following a comprehensive assessment, intervention, evaluation and re-intervention by an RN, restraints may be removed. Patient debriefing is required as soon as possible after restraint is removed and is documented. Debriefing occurs as soon as possible, but no longer than 24 hours, after each episode and documented in the medical record.
PRN Orders - No."

In an interview with the facility's director of clinical effectiveness on 3/3/15 at 11:45 a.m., he/she acknowledged the timeframes listed under "Patient Evaluation For Continued Use of Restraints" did not reflect the timeframes required by §482.13(e)(8).

During the end of day conference on 3/3/15, the facility's director of clinical effectiveness along with the medical/surgical and cardio/pulmonary manager, the facility's restraint policies and the differences between non-violent and violent/self-destructive behavior were discussed.

Based on staff interviews, facility document review, and during the course of a complaint investigation it was determined the facility's physician and physician assistant did not demonstrate a working knowledge of the facility's restraint policies nor did the facility's restraint policies address training requirements for physicians and other licensed independent practitioners.

The findings were:

While interviewing one of the facility's physicians (Physician #1) on 3/3/15 at 4:05 p.m. about restraint use, the physician stated the nurses at the facility are knowledgeable about restraints and know how to comply with restraint usage policy. When asked whether a patient who was attempting to hit and spit on staff would require violent versus non-violent restraints, the physician stated, "If punching I guess it would be violent."

During an interview with one of two physician assistants (PA #1) on 3/3/15 at 1:45 p.m., PA #1 was asked about restraint usage related to Patient #2's electronic medical record. PA #1 stated the patient had wrist and ankle restraints due to possible overdose of drugs (O.D.)/possible suicide attempt because he/she didn't want to medicate the patient at that time. When asked whether punching at staff and/or spitting at staff would require non-violent versus violent restraints, PA #1 stated he/she wasn't sure what the facility policy stated but reiterated that the particular patient at question (Patient #2) required restraints since he/she wouldn't medicate the patient at that time and he/she had been called about the patient spitting in nurses' faces.

The facility's accreditation manager was interviewed on 3/4/15 at 12:00 noon. The accreditation manager stated no policy/procedure could be found to address restraint training for physicians; he/she stated restraint training for physician was not found in the bylaws or the rules and regulations. The manager provided the survey team with a copy of an human resource policy/procedure entitled, 'COMPETENCY VALIDATION PROCESS' which discussed developing competencies related to the use of restraints; this policy/procedure specifically stated it did not apply to "employees with medical staff privileges." (Both physicians and physician assistants have medical staff privileges at this facility.) The accreditation manager also provided the survey team with a nursing policy/procedure entitled, 'Restraint, Use of ' and stated the 'Restraint, Use of ' policy/procedure would not apply to the physician but he/she was unsure if it would apply to the physician assistants. On 3/4/15 at 12:05 p.m., the facility's Medical Staff Coordinator confirmed that the nursing policy/procedure 'Restraint, Use of ' would not apply to the physician assistants.

During an interview on 3/4/15 at 12:10 p.m., the accreditation manager provide the survey team with a copy of a blank 'Physician Orientation Guide;' the topic of restraints was included under the patient care section of this guide. The manager stated neither Physician #1 nor Physician #2 had evidence they completed this 'Physician Orientation Guide." He/she also reported that Physician Assistant (PA) #1 had no evidence of training related to restraints; the manager was still looking for evidence of restraint training for Physician Assistant (PA) #2. Later on the afternoon of 3/4/15 the survey team was provided a copy of an email sent to the accreditation manager. The email stated that both PA #1 and PA #2 had been assigned restraint training per their training transcripts, but neither had completed the training.

Based on staff interviews, electronic medical record review, and during the course of a complaint investigation it was determined the facility staff failed to ensure 2 of 2 patients with violent or self destructive behavior restraints were seen by a physician or licensed independent practitioner within 1-hour of initiation of wrist and ankle restraints. (Patient #2 and Patient #5).

The findings were:

1. Patient #2's electronic medical record was reviewed throughout the survey. The initial restraint order was a verbal order written with telephone readback by a registered nurse (RN) on 1/10/15 at 1921 (7:21 p.m.). Although the order was written for "non-violent" wrist and ankle restraints, progress notes within the record indicated Patient #2's behavior could be self-destructive/aggressive. Progress Notes documented:
a) 1/10/15 at 6:15 p.m. - "Staring into the air reaching for things that are not there, hitting hands on bedrails, kicking feet into side of bed, grabbed catheter [sic] and pulled tubing nearly apart, hitting at staff. Talks in complete sentences at will then grunts and moans at other times. (Physician's name) notified of agitation, new orders noted."
b) 1/10/15 at 7:30 p.m. - "... Patient is in bed, restrained. Remains agitated. Pulling on foley, monitor leads and other equipment. Attempting to hit staff and spit on staff. Unable to calm. Patient unable to follow commands. Will medicate and ordered [sic] and monitor for effectiveness. Unable to complete assessment or obtain vital signs at this time. Will complete when patient calmer."
c) 1/10/15 at 7:35 p.m. - "(Patient's child) called requesting to speak to patient. Patient agitated, pulling on restraints. Unable to cooperate with staff. Informed (patient's child) that patient and staff unable to talk to (him/her) at this time. (He/She) should call back later."
d) 1/11/15 at 7:26 a.m. - "(Patient) calm at this time, no distress noted. (Patient) remains in restraints. Report received from previous shift. Assessment completed, see doc flow sheets. (Patient) was restless when this nurse did assessment, however, (he/she) is calm at this time. (Patient) remains 1:1 observation. Will continue to monitor."
e) 1/11/15 at 4:20 p.m. - "(Patient) still appears to be sleeping. When (he/she) does wake up (he/she) is still grunting and trying to pull at catheter and IV tubing despite (he/she) restraints. Will continue to monitor."
f) 1/11/15 at 6:59 p.m. stated, "...(Patient) still combative at times, asleep most of shift. No distress noted..."

Patient #2's discharge summary completed by Physician Assistant (PA) #1 on 1/11/15 at 5:23 p.m. and cosigned by Physician #1 on 1/19/15 at 9:42 a.m. included the following information:
- "Patient continues to only grunt and make occasional demands - moving all extremities remains agitated and aggressive."
- "Constitutional: (vital signs stable). Patient is responsive to pain, noxious stimulus, and will request things at (his/her) leisure - otherwise aggressive and grunting. Remains in 4 point restraints due to aggressive behavior."

Patient #2's electronic medical record included a section entitled 'Care Plan.' Under the 'Care Plan' section the following information was found: "Problem: Restraint Use (Adult, OB, Pediatrics)" with a start date of 1/10/15. Under the "Problem: Restraint Use (Adult, OB, Pediatrics)" were 'interventions' which include the two following: (a) Intervention: Enhance behavior management - Dates: Start: 01/10/15 - Frequency: AS NEEDED - Description: Violent/Self Destructive, Aka [sic] Behavior Health Restraint USE ONLY [sic] and (b) Intervention: Provide debriefing (violent/self destructive only) - Dates: Start: 01/10/15 - Frequency: AS NEEDED - Description: Violent/Self Destructive. The aforementioned care plan included a 'frequency' of 'as need' but the physician assistant order (cosigned by a physician) was not written as an 'as needed' order.

During an interview with Physician Assistant (PA) #1 on 3/3/15 at 1:40 p.m., PA #1 stated Patient #2's bilateral wrist and bilateral ankle restraints were due to the patient being combative, aggressive, and punching staff.

During an interview with Physician #1 on 3/3/15 at 4:00 p.m., Physician #1 was asked about the reason, violent or nonviolent, for Patient #2's restraint order that he/she had cosigned. After discussing Patient #2's presentation/situation at the time of the restraint order, Physician #1 stated, "If punching I guess it would be violent."

Evidence of a face-to-face evaluation by a physician or licensed independent practitioner within 1 hour of the initiation of wrist and ankle restraints was not found within the chart or provided by the facility staff.

2. Patient #5's electronic medical record was reviewed in the morning of 3/4/15. The initial restraint order was a verbal order taken with verbal readback by a registered nurse on 1/8/15 at 1723 (5:23 p.m.). Although the restraint order was for "non-violent" wrist and ankle restraints, progress notes within the record indicated Patient #5's behavior could be combative.
Progress notes related to restraints/behavior documented:
- on 1/8/15 at 2:30 p.m. - "(Patient appears to be slightly anxious at this time, however, CIWA (Clinical Institution Withdrawal Assessment) score is only 4 at this time. (Patient) refused medications at this time. Will continue to monitor."
- on 1/8/15 at 2:55 p.m. - "(Patient) trying to pull out foley catheter at this time. Ativan 1 mg given at this time per order of (Physician Assistant). CIWA score is 23 at this time. Foley catheter is removed at this time, (patient) tolerated well. Will continue to monitor."
- on 1/8/15 at 3:27 p.m. - "(Patient) sitting up in chair at this time states that (he/she) feels better. Will continue to monitor."
- on 1/8/15 at 4:10 p.m. - "Walked into (patient's) room, (patient) has spilled an entire pitcher of ice water on floor and pulled out (his/her) 18 gauge IV. (Physician Assistant) informed. Ativan 2 mg IV given at this time, CIWA score 27. Will continue to monitor."
- on 1/8/15 at 4:45 p.m. - "(Patient's) family present at this time. Attempting to convince (patient) to stay, (patient) refusing, wanting to sign out AMA. (Patient) unsteady on feet and pulling at IV lines. (Physician Assistant) notified."
- on 1/8/15 at 5:15 p.m. - "(Patient) placed in four point soft restraints at this time per order of (Physician Assistant) due to (patient) pulling at IV lines and foley catheter. Ativan 2 mg IV given at 1710 for agitation, CIWA score 33. Will continue to monitor."
- on 1/8/15 at 6:14 p.m. - "(Patient) becoming very confused and combative as the evening progressed. Hallucinating. Tremor. Full active DTs. Contacted family and discussed POC. (Patient) restrained for safety - medicated per CIAWA [sic] protocol - continue treatment per pathway. Notified and discussed with (physician). Likely 2-3 more days."
- on 1/8/15 at 6:48 p.m. - "End of shift note. (Patient) still sedated, resting quietly, four point restraints intact. Will report to oncoming shift."
- on 1/9/15 at 2:18 a.m. - "Inserted foley catheter."

Evidence of a face-to-face evaluation by a physician or licensed independent practitioner within 1 hour of the initiation of wrist and ankle restraints was not found within the chart or provided by the facility staff.

The facility's policy/procedure titled, "Restraints, Use of " with a last updated date of 10-2014 was reviewed on 3/3/15 and 3/4/15. Under "Implementation of Restraints," the procedure separated the information into two columns, one titled, "Non-Violent Restraints" and the second titled, "Violent Use Restraints." For Violent Use Restraints, the procedure documented, in part:
"Use of Restraints - Emergency situations where behavior is dangerous, violent, or aggressive. Also used to protect the patient from injury to self or others. Applicable regardless of patient care settings.
Initial Order - LIP, NP, or PA must see and evaluate patient within one (1) hour of initiation of restraints for behavioral health purposes.

In an interview with the facility's director of clinical effectiveness on 3/3/15 at 11:45 a.m., he/she acknowledged the timeframes listed under "Patient Evaluation For Continued Use of Restraints" did not reflect the timeframes required by §482.13(e)(8).

During the end of day conference on 3/3/15, the facility's director of clinical effectiveness along with the medical/surgical and cardio/pulmonary manager, the facility's restraint policies and the differences between non-violent and violent/self-destructive behavior was discussed.