The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

SWEDISH MEDICAL CENTER 747 BROADWAY SEATTLE, WA 98122 March 9, 2017
VIOLATION: PATIENT RIGHTS Tag No: A0115
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Based on observation, interview, record review, and review of hospital policies and procedures, the hospital failed to protect and promote patient rights.

Failure to protect and promote each patient's rights risk the patient's loss of each patients' basic rights, loss of patient safety, personal freedom, and the inappropriate use of restraint or seclusion.

Findings:

1. Failure to allow patients to receive care in a safe setting.

2. Failure to allow patients to be free from restraints and not used as part of a falls prevention program.

3. Failure to monitor the restrained patient by a physician or other LIP, as determined by hospital policy.

The cumulative effect of these systemic problems resulted in the hospital's inability to provide for patient safety and protect patient rights.

Due to the scope and severity of deficiencies under 42 CFR 482.13, the Condition of Participation for Patient Rights was NOT MET.

Cross Reference: Tags A0144, A0154, A0165, A0168, A0174, A0175, A0179.
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VIOLATION: MEDICAL STAFF - ACCOUNTABILITY Tag No: A0049
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Based on document review and interview, the hospital failed to ensure that physicians and licensed independent practitioners (LIP) had evidence of required training regarding the use of restraints and seclusion.

Failure to ensure required training places patients at risk for physical and psychological harm, loss of dignity, and violation of patient rights.

Findings included:

1. The hospital's policy "Education/Orientation of Credentialed Practitioners Regarding the use of Restraint and Seclusion" dated 05/2016 stated "2. The application also contains a form, Regulatory Compliance Document (RCD), which includes the reference to the Restraint or Seclusion Management Clinical Procedure, and the applicant attests to the information received."

The policy further indicated that "5. Every two years credentialed practitioners are required to complete a reappointment application to maintain medical staff membership and privileges, contained in the reappointment application is the Regulatory Compliance Document (RCD), which includes the reference to the Restraint or Seclusion Management Clinical Procedure, and the applicant attests to the information received."

2. On 3/7/2017, Surveyor #1 reviewed three physician's initial credential application files (Physicians H, J, K) since the date of the implementation of the policy. One (Physician K) of three initial credential files reviewed contained the attestation form.

3. On 03/07/2017, Surveyor #1 reviewed four physician and three licensed independent practitioner reappointment files. There was no attestation form or evidence of training for the physicians/LIPs (Physicians A, B, D, E, F, G, H).

4. On 03/07/2017, at 3:00 PM, surveyor #1 interviewed the Director of Medical Staff Services (Staff O) regarding the initial and reappointment process for training credentialed practitioners. H/She stated that the hospital was gradually phasing in the attestation form for both the initial and reappointment credential process. H/She confirmed the files did not contain the attestation forms.

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VIOLATION: GOVERNING BODY Tag No: A0043
Based on observations, interviews and document review, the hospital failed ensure patient safety related to the use of restraints and seclusion.

Failure to do so creates risk to patient safey and violations of patient rights.

Findings:

1. The Governing Body failed to effectively provide oversight for the use and application of patient restraints as evidence by the IMMEDIATE JEOPARDY condition idenfitied on 3/03/2017.

2. Due to the scope and severity of deficiencies detailed under 42 CFR 482.13, the Conditions of Participation for Governing Body are NOT MET.

Cross -Reference: Tags A0049, A0050.

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VIOLATION: MEDICAL STAFF - SELECTION CRITERIA Tag No: A0050
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Based on document review, medical record review and interview, the hospital failed to identify which categories of practitioners who were authorized to conduct the one hour face to face evaluation for the use of violent or self-destructive behavior restraints or seclusion.

Failure to identify which practitioners are authorized to conduct the one hour face to face evaluation, creates a risk of patient harm due to potentially being inappropriately placed in restraints or seclusion.

Findings included:

1. On 03/07/2017, Surveyor #1 reviewed the Medical Executive Committee minutes dated 02/24/2016. The minutes indicated "III. Consent Agenda, E. Restraints (Violent/Seclusion) face to face evaluation delegated to PACS {physician assistant certified} and ARNPS {advanced registered nurse practitioner}, approved."

2. On 03/07/2017, Surveyor #1 reviewed the Medical Executive Committee Agenda item related to the above minutes, undated. This document stated "The system-wide Restraint Compliance Governance Committee recommends MEC approval for our hospitals to allow appropriately trained ARNPs and PAs to conduct the face to face evaluations when restraints to manage violent behavior or seclusion has been ordered by the Attending Provider or the individual (with appropriate licensure) acting on their behalf. Currently SMC policy does not allow this".

The document further stated "ARNPS and PA-Cs of defined clinical areas will receive related training as part of their credentialing/onboarding (via online module used nationally). If MEC approves, the training will be pushed to existing staff-with competencies documented-prior to policy revision and implementation."

3. On 03/07/2017, at 3:00 PM, Surveyor #1 interviewed the Director of Medical Staff Services (Staff O) and the Accreditation Specialist (Staff B). The following was revealed:

a. Most of the PACs and ARNPs were based in four emergency departments (First Hill, Ballard, Mill Creek, and Redmond). Each department decided which PACs and ARNPs could conduct the face to face evaluation. This was not written in any document.

b. The hospital's policies or Medical staff bylaws had not been amended to reflect the Medical Executive Committee's approval for PACs and ARNPs authority to conduct the one hour face to face evaluation.

4. On 03/08/2017, at 11:30 AM, Surveyor #1 interviewed the Chief Nursing Officer (CNO) of the Swedish Ballard campus (Staff S). The interview revealed the following:

a. The Behavioral Health Unit at the Ballard campus had begun a three month pilot program in January 2017. The pilot program was sponsored by the CNO and the Vice President of Medical Affairs. The pilot program allowed the critical care float Registered Nurses (RN) to conduct the one hour face to face evaluation for the use of violent/self-destructive behavior restraints and seclusion.

b. The critical care float RNs had all completed the American Psychiatric Nurses Association (APNA) online training module.

c. The hospital's policies and procedure and Medical staff bylaws had not been amended to authorize the use of critical float RNs at the Ballard campus to conduct the one hour face to face evaluation for the use of violent/self-destructive behavior restraints and seclusion.

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VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

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Based on record review and review of hospital policies and procedures, the hospital failed to ensure hospital staff protected a vulnerable patient (Patient #1) managed under high risk fall precautions.

Failure to provide protection for vulnerable patient's emotional health and physical safety can lead to permanent harm and/or death.

Findings:

1. Review of the hospital's policy titled "FALL PREVENTION," Approved 10/2010 showed that the hospital staff will assess all inpatients for fall risk using the "Johns Hopkins Screen" and when completed a score will determine the patient's risk - low, moderate, or high. High risk interventions include: following low & moderate interventions, plus communicate fall status to other hospital disciplines, and purposeful rounding. Fall prevention interventions also include, "Risk - Targeted Interventions" for patients with observed mental status (confused, impulsive, inability to follow directions) implementation can include (but not limited to) "8 Consider using an electronic exit alarm monitor (bed or chair alarm) ..."

2. On 3/3/17 at 9:00 AM, Surveyor #2 reviewed the medical record for Patient #1. Review of the record showed a [AGE] year old patient admitted directly to the intermediate intensive care unit (MICU) with gastrointestinal bleeding and cirrhosis. The patient was admitted with a blood alcohol level > 300 and placed on alcohol withdrawal management and high fall risk prevention. A registered nurse's (RN) note dated 2/16/17 at 6:33 AM, stated that the patient found was "sitting on the floor at the foot of the bed," patient was drowsy and weak. The RN's noted continues with "bed exit alarm was on but did not alarm. Rechecked the bed and it was all connected." There was no documentation found that this bed's "exit alarm" continued to be used on this patient or that the alarm was reported or sent for repair.

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VIOLATION: USE OF RESTRAINT OR SECLUSION Tag No: A0154
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

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Based on document review, medical record review and interview, the hospital failed to ensure restraints (Patient #5) were imposed for the immediate physical safety of the patient or staff member.

Failure to ensure restraints are imposed for the immediate physical safety, places patients at risk for physical and psychological harm, loss of dignity, and violation of patient rights.
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Findings include:

1. On 03/03/2017, Surveyor #1 reviewed the "Restraint or Seclusion Management Clinical Procedure" dated November 2016. The policy stated "indications for restraint are: .....Violent Track: To restrict a patient's movement for the management of violent or self-destructive behavior that jeopardized the immediate physical safety of the patient, staff members, or others."

The policy stated to call a Code Gray {an immediate response team to de-escalate a patient's violent behavior} if a patient's behavior escalates toward violent harm to self, staff or others.

The policy further stated: "Prerequisite Information, 1) The restraint or seclusion chosen is the least restrictive intervention that protects the patient's or others' safety.....Restraint/seclusion is initiated only after evaluating the patient and determining the use of the alternatives to restraint or less restrictive measures poses a greater threat...4) A history of falls, dangerous behavior, a family's request, or the possibility that the patient's behavior may place him or her at risk is not sufficient reason to justify the use of restraint..." "Initiation of restraint or seclusion, 2) Notify the LIP and obtain an order prior to or immediately, not to exceed one hour after restraint application."

2. On 03/03/2017, at 10:30 AM, surveyor #1 reviewed the medical record of patient #5. The review revealed the following:

a. Patient #5, a 53 year old, was admitted on [DATE] to the Intensive Care Unit for management of alcohol withdrawal symptoms and was on a Clinical Institute Withdrawal Assessment (CIWA) protocol to manage the patient's symptoms (the protocol consists of a scoring system to assess the severity of the patient's symptoms and medications to manage the symptoms).

b. Patient #5 had been in a Posey (a torso vest that ties in the back and prevents a patient from getting out of bed) vest restraint and soft bilateral wrist restraints on and off since admission. The documentation indicated this was for "risk of accidental self-injury." The orders for the Posey vest restraint and the soft bilateral wrist restraints were Medical Interference restraint orders.

c. Ongoing behavior issues such as verbal and physical aggression toward staff, agitation, multiple nurses being bruised by kicking and swinging were present in the medical record.

3. On 3/03/2017, at 11:00 AM, Surveyor #1 interviewed the patient's hospitalist physician (Physician A) and the Charge Nurse (Staff G) of the unit. The interview revealed the following:

a. There had been three code gray's called regarding patient #5's behavior since admission.

b. Patient #5 was in a Posey vest and bilateral wrist restraints at the time of the interview.

c. When asked for the indications to remove Patient #5 from the restraints, Physician A stated that when the patient had gone 24 hours without attempting to or actually hitting staff, the restraints would be removed. He further stated that security would advise him on this matter.

4. On 03/03/2017, Surveyor #1 reviewed the Security Incident Report (code gray form) for Patient #5. The report stated the incident occurred 02/23/2017 at 5:47 PM. The report stated that the RN (Staff J), assigned to Patient #5 related that the patient was combative with him/her and striking him/her in the right arm. The RN had given the patient medication but was "fearful that the medication will not work and wants {Patient 5} in restraints for her safety while h/she works....All officers entered the room and went hands on with {Patient 5} who was sleeping at the time."

5. On 03/03/2017, at 01:15 PM, Surveyor #1 interviewed the RN (Staff J) assigned to Patient #5 during the time of the code grey. The interview revealed the following:

a. At the time of the code gray, Patient #5 was in a Posey Vest restraint. Patient #5 had been "kicking, agitated, and combative." As a response to this behavior, Patient #5 had been medicated with 8 mg of Ativan intravenous (a medication to decrease aggressive behavior) and 1mg Haldol intravenous (a medication to decrease aggressive behavior).

b. The RN (Staff J) called the code gray. She told the response team that "she would really like the patient in 4 point hard restraints." The RN indicated that the Charge Nurse (Staff K) who responded to the code grey disagreed with that intervention. When asked about an LIP order for the restraints, the RN stated she thought the Intensive Care Unit physician (Physician B) on duty gave a verbal order.

d. On 03/03/2017, at 2:00 PM, Surveyor #1 interviewed the Charge Nurse (Staff K) who responded to the code gray for Patient #5. The Charge Nurse stated that the RN (Staff J) "wanted the patient in 4 point restraints." The Charge Nurse disagreed with that intervention as the patient was "groggy" and not combative at the time.

6. On 03/07/2017 at 1:30 PM, Surveyor #1 interviewed the Intensive Care Unit physician (Physician B) via telephone. The interview revealed the following:

a. Physician B was physically on duty on 02/ 23 /2017 in the Intensive Care Unit (ICU) during the code gray. The physician was not assigned to Patient #5.

b. Physician B recalled that the RN (Staff J) had wanted help. He stated he entered a medication order for Haldol in the electronic ordering system.

c Physician B stated he did not enter or give a verbal order for violent/self- destructive behavior 4 point hard restraints.

d. Physician B stated he did not conduct a face to face evaluation of Patient #5.

7. On 03/03/2017, Surveyor #1 reviewed Patient #5's medical record for 02/23/2017. The medical record did not contain an order by an LIP for the 4 point restraints and the one hour face to face evaluation as required for violent/self-destructive restraints had not been documented.

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VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0165
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

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Based on record review and review of hospital policies and procedures, the hospital failed to ensure hospital staff used the least restrictive intervention while using physical restraints on a patient (Patient #1).

Failure to choose the least restrictive restraint risks physical or psychological trauma to patients and/or death.

Findings:

1. Review of the hospital's policy titled "Restraint or Seclusion Management," Approved 11/2016 showed that the restraint chosen is the "least restrictive" that protects the patient's safety and the restraint is to be discontinued at the "earliest possible time."

2. On 3/3/17 at 9:00 AM, Surveyor #2 reviewed the medical record for Patient #1. Review of the record showed a [AGE] year old patient admitted directly to the intermediate intensive care unit (MICU) with gastrointestinal bleeding and cirrhosis. The patient was admitted with a blood alcohol level > 300 and placed on alcohol withdrawal management and high fall risk prevention. A registered nurse's (RN) assessment performed on 2/15/17 at 11:30 AM, described the patient's level of consciousness as "arousable," orientation level as "oriented", and behavior/cognition as "cooperative." The same observations were entered by the nurse on 2/16/17 at 1:00 AM. A nurse shift summary report dated 2/15/17 at 5:40 AM, described the patient as "calm and cooperative with care." On 2/16/17 at 4:00 AM, the patient was placed in physical restraints after being found "sitting on the floor at the foot of the bed," while the bed's exit alarm did not sound but was connected. The nurse shift summary report on 2/16/17 at 0633, stated that the patient sustained no apparent injury and the attending physician ordered a "posey vest restraint." Same note stated the patient was "cooperative and quiet the rest of the night." According to restraint documentation, the patient remained in the posey vest until the restraint was discontinued on 2/19/17 at 4:49 PM. There was no documentation found that staff determined that less restrictive alternatives would not meet the patient's clinical needs, or protect the patient's safety.

3. Review of the initial physician's restraint order dated 2/16/17 at 3:58 AM, stated order restraint for "Medical Interference-Adult type" and type of restraint as "soft-limb: 2 point; plus vest immobilizer restraint." There was no documentation found that the staff applied soft-limb: 2 point restraints on the patient.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0168
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Based on document review and interview, the hospital failed to identify which categories of licensed independent practitioners (LIP) had the authority to order restraint and seclusion.

Failure to identity which LIPs have the authority to order restraint and seclusion creates a risk of patient harm due to potentially being inappropriately placed in restraints or seclusion.

Findings included:

1. On 03/09/2017, Surveyor #1 reviewed the hospital's medical staff bylaws. There was nothing in the Medical staff bylaws about which categories of practitioners had the authority to order restraint and seclusion. Surveyor #1 also reviewed ten physician and LIP credential files. The files did not contain evidence of a practitioner having the authority to order restraint or seclusion.

2. On 03/09/2017, Surveyor #1 reviewed the hospital's policy "Restraint or Seclusion Management Clinical Procedure" dated November 2016. There was nothing in the policy about which practitioners had the authority to order restraint and seclusion.

3. On 03/07/2017 at 2:00 PM, Surveyor #1 interviewed the Director of Medical Staff Services (Staff O) and the Accreditation Specialist (Staff B). They confirmed that the hospital did not have a policy or document that identified which categories of practitioners had the authority to order restraint and seclusion.

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VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0174
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on document review, medical record review and interview, the hospital failed to discontinue seclusion for one patient (Patient #6) at the earliest time possible.

Failure to discontinue seclusion at the earliest time possible, places patients at risk for physical and psychological harm, loss of dignity, and is a violation of patient rights.

Findings included:

1. On 03/03/2017, Surveyor #1 reviewed the "Restraint or Seclusion Management Clinical Procedure" dated November 2016. The policy stated "Prerequisite Information, 1) Restraint or seclusion chose is the least restrictive intervention that protects the patient's or others' safety and is to be discontinued at the earliest possible time".

2. On 03/08/2017, Surveyor #1 reviewed the medical record for Patient #6. The review revealed the following:

a. Patient #6 was a [AGE] year old who was brought to the Ballard Campus Emergency Department (ED) on 02/25/2017at 08:30 AM via ambulance for manic behavior. Patient #6 had a history of involuntary psychiatric admissions with a diagnosis of Bi-Polar disorder (mental health disease with manic and depressive phases). Patient#6 was in 4 point hard restraints on arrival (placed by the Medics) and was immediately placed in the seclusion room. Patient #6 was described as agitated, at times yelling and screaming and rambling in speech. A PSA (patient safety attendant) was at the bedside with the patient.

b. At 02:35 PM, the left wrist hard restraint on Patient #6 was removed. At 02:45 PM, the right wrist hard restraint was removed. At 03:00 PM, all 4 restraints had been removed. The patient remained in seclusion. The nursing note at 15:04 stated "the patient appears more calm after the release of restraints". The nursing note at 04:18 PM stated the "Patient has been redirectable and cooperative with staff. Seclusion continues with PSA (patient safety attendant) at bedside. Awaiting MHP (mental health professional) evaluation."

c. Restraint flow sheet documentation from 03:00 PM to 08:15 PM indicated the patient was at times asleep, awake/alert/tearful, yelling, and rambling conversation.

d. At 06:30 PM Patient #6 was involuntarily detained by the Mental Health Professional. At 08:15 PM Patient #6 was transferred to the Ballard Behavioral Health Unit (BHU). On admission to the BHU, patient was not placed in seclusion. Patient #6 was in seclusion in the ED for 12.5 hours.

e. On 03/08/2017, at 10:30 AM, Surveyor # 1 interviewed the Manager, ED for the Ballard Campus (Staff V). When asked about indications of patient #6 to be be released from seclusion in the ED, h/she indicated the patient remained in seclusion due to an elopement risk and while awaiting the mental health professional evaluation.

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VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0175
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Based on record review and review of hospital policies and procedures, the hospital failed to ensure medical staff or other licensed staff appropriately monitor the condition of patients who were restrained as observed in 3 out of 10 records reviewed (Patients #2, #3, #4).

Failure to appropriately monitor restrained patients can lead to the unnecessary use of restraints or seclusion longer then believed to be reflective of the patient's condition and overlooked assessments regarding continued need for the use of seclusion or restraints.

Findings:

1. Review of the hospital's policy titled "Restraint or Seclusion Management," Approved 11/2016 showed that a licensed independent provider (LIP) or trained staff will conduct a "face to face evaluation of the patient" within one hour of restraint application for violent behavior and within 24 hour of restrain application for medical interference.

2. On 3/7/17 at 10:00 AM, Surveyor #2 reviewed the medical records for Patients #2, #3, #4 and observed the following:

a. Patient #2 was directly admitted to the intermediate intensive care unit (MICU) for severe alcohol and opiate withdrawal. Initially an order for violent behavior restraints was implemented upon admission to the unit on 12/2/16. The patient's behavior improved and an order for medical interference restraints was implemented on 12/3/16. A 24 hour required face to face evaluation completed by a LIP could be found in the record for restraint day 12/4/16.

b. Patient #3 was a critically ill patient with a history of cancer, now in a coma after experiencing a questionable seizure at home and was receiving care in the intensive care unit (ICU). The patient was intubated (breathing tube), had a urinary catheter, and a stomach feeding tube. A medical interference restraint order was implemented on 12/24/16 to prevent dislodgement of a urinary drainage tube, airway tube, stomach tube, and intravenous lines. On 12/30/16 the patient's condition was assessed and restraints were discontinued 4:00 PM. A 24 hour required face to face evaluation completed by a LIP could be found in the record for restraint days 12/26/16 and 12/27/16.

c. Patient #4 was a patient transported to the emergency department (ED), on 1/24/17 at 1:27 PM, requiring evaluation for possible narcotic ingestion. The patient was escorted by the local police department and restrained in law enforcement (LE) cuffs. The ED provider entered an order for LE restraints at 1:50 PM and 4-point restraints were safely applied to the patient at 1:00 PM. The ED staff monitored and documented patient safety in the restraint flowsheet as required. The patient underwent evaluation, observation, and eventually discharged into police custody at 5:40 PM. An LIP one- hour required face to face assesssment could be found in the record.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0179
Based on document review and interview, the hospital failed to ensure training of LIPS who were authorized to conduct the one hour face to face evaluation for the use of violent or self-destructive behavior restraints or seclusion.

Failure to ensure training for LIPS who were authorized to conduct the one hour face to face evaluation, creates a risk of patient harm due to potentially being inappropriately placed in restraints or seclusion.

Findings included:

1. On 03/07/2017, Surveyor #1 reviewed the Medical Executive Committee minutes dated 02/24/2016. The minutes indicated "III. Consent Agenda, E. Restraints (Violent/Seclusion) face to face evaluation delegated to PACS {physician assistant certified} and ARNPS {advanced registered nurse practitioner}, approved."

2. On 03/07/2017, Surveyor #1 reviewed the Medical Executive Committee Agenda item related to the above minutes, undated. This document stated "The system-wide Restraint Compliance Governance Committee recommends MEC approval for our hospitals to allow appropriately trained ARNPS and PAs to conduct the face to face evaluations when restraints to manage violent behavior or seclusion has been ordered by the Attending Provider or the individual (with appropriate licensure) acting on their behalf. Currently SMC policy does not allow this".

3. On 03/07/2017, at 3:00 PM, Surveyor #1 interviewed the Director of Medical Staff Services (Staff O) and the Accreditation Specialist (Staff B). The following was revealed:

a. There were no specific privileges for PACs and ARNPs to conduct the face to face evaluation for the use of violent/self-destructive behavior restraints or seclusion.

b. Most of the PACs and ARNPs were based in four emergency departments (First Hill, Ballard, Mill Creek, and Redmond). Each department decided which PAC and ARNPS could conduct the face to face evaluation.

c. The training determined for PACs and ARNPs to conduct the one hour face to face evaluation was the online module by the American Psychiatric Nurses Association (APNA).

d. Evidence of the training was not contained in the credential files.

4. On 03/09/2017, at 11:15 AM, during an interview with Surveyor #1, the Administration Director Accreditation, Safety, CQI confirmed that there was no evidence of training for the ARNPs and PACs who conducted the one hour face to face evaluation.

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