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.

MARIA PARHAM MEDICAL CENTER PO BOX 59 HENDERSON, NC 27536 Jan. 15, 2015
VIOLATION: PROGRAM SCOPE, PROGRAM DATA Tag No: A0273
Based on restraint list/log documentation reviews, observations during tour, and staff interviews the hospital failed to have the Quality Assessment Performance Improvement (QAPI) program monitoring the effectiveness and safety of involuntary commitment (IVC) patients restrained by Law Enforcement Officers in the ED.

The findings include:

Interview on 01/14/2015 at 1420 during tour of the ED (1420-1500) with Charge Nurse #2 revealed the ED had three (3) patients currently under involuntary commitment (IVC) in exam rooms #1, #5, #17 and one (1) patient pending IVC in exam room #7. Observations during tour revealed all 4 patients (#13, #14, #17, #16) in the aforementioned exam rooms were observed in restraints (handcuffs/shackles) applied by Law Enforcement Officers.

Review of a "Restraint List" dated 01/15/2015 at 1501 for the Hospital's nursing units and ED from 01/14/2015 at 0000 to 01/15/2015 at 1501 revealed no documentation of the names of Patients #13, #14, #17, and #16 observed in restraints during the ED tour on 01/14/2015 at 1420-1500.

Interview on 01/15/2015 at 1235 with the ED Nursing Director revealed patients placed into "forensic" restraints (handcuffs/shackles) by law enforcement officers are not placed on the restraint log and are not reported quarterly.

Interview with the Director of Quality Management on 01/15/2015 at 1427 revealed she maintains the hospital's restraint log. Interview revealed she reviews inpatient restraints. Interview revealed "the hospital had not been looking at restraints from an ED perspective until December 2014." Interview revealed the hospital had revised the restraint policy to make the policy more compliant. Interview revealed the ED Director is responsible for reviewing restraints in the ED. Interview revealed the hospital is not currently looking at "forensic" restraints applied by law enforcement officers. Interview revealed "We're not looking at patients in forensic restraints from a quality perspective." Interview revealed "I have no data for that population (patient's restrained by law enforcement)." Interview revealed the hospital staff failed to include ED patients placed in restraint by law enforcement officers in their restraint data.
VIOLATION: NURSING SERVICES Tag No: A0385
Based on Hospital policy/procedure review, Hospital administrative staff interview, medical record reviews, observations, staff/physician interviews and Law Enforcement Officer (LEO) interviews the hospital nursing staff failed to ensure nursing supervision of care per the hospital policy and procedure when the staff failed to provide ongoing assessment and monitoring of the condition of patients during restraint or seclusion in the emergency department (ED) who were under involuntary commitment (IVC) and of intensive care unit (ICU) patients not under IVC.

The findings include:

The hospital's nursing staff failed to provide ongoing assessment and monitoring of the condition of a patient during restraint or seclusion for 6 of 6 emergency department (ED) patients (#14, #16, #13, #17 #12, #9) under involuntary commitment (IVC) and 1 of 1 intensive care unit (ICU) patients not under IVC (#2).

~cross refer to 482.23(b)(3) Nursing Services Standard - Tag A0395.
VIOLATION: RN SUPERVISION OF NURSING CARE Tag No: A0395
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based upon hospital policy and procedure reviews, observations during tours, medical record reviews, Law Enforcement Officer (LEO) interviews, staff and physician interviews, the hospital's nursing staff failed to provide ongoing assessment and monitoring of the condition of a patient during restraint or seclusion for 6 of 6 emergency department (ED) patients (#14, #16, #13, #17 #12, #9) under involuntary commitment (IVC) and 1 of 1 intensive care unit (ICU) patients not under IVC (#2).

The findings include:

Review of current hospital policy "Restraint of Patients, PC 17", revised 12/2014, revealed "PURPOSE: The use of restraints is a therapeutic intervention implemented to prevent the patient from injuring himself/herself or from injuring others. The decision to use a restraint is driven by a comprehensive individual assessment. This document is used to provide consistent guidelines for the safe use of chemical and physical restraints and seclusion, if alternatives, as determined by an interdisciplinary team, have proven to be clinically ineffective to provide a safe environment for the patient. ...DEFINITIONS: Restraint - is the direct application of physical force to a patient, with or without the patient's permission, to restrict his or her freedom of movement. The physical force may be human, mechanical devices, or a combination thereof. Physical Restraints - any manual method or physical/mechanical device, material or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely. ...Restraint to Promote Medical Recovery (non-violent): refers to the use of restraints in those patients who require various medically essential therapies while hospitalized and who demonstrate a state of confusion or altered cognition that puts those therapies at risk OR those patients who require management of non-psychiatric behaviors that put them at risk for injury. Restraints for Violent or Self-Destructive Behavior: refers to the use of restraints in those patients who require management of violent or self-destructive behavior towards themselves or others (including caregivers or other patients) or, who require physical restraint to manage suicidal or homicidal behaviors in ANY setting. ...Restrictive Devices Applied by Law Enforcement Officials - handcuffs and other restrictive devices applied by law enforcement officials for custody, detention, and public safety reasons and is not involved in the provision of health care; no considered restraints. ...Seclusion - seclusion is the involuntary confinement of a patient alone in a room or area from which the patient is physically prevented from leaving. Seclusion may only be used for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others. The following interventions are not considered seclusion: 1. a patient physically restrained alone in an unlocked room. ...POLICY: It is the policy of (Hospital name) Medical Center to: 1. Prevent, reduce and eliminate the use of restraints by: a. preventing emergencies that have the potential to lead to the use of restraints, b. limiting the use of restraints to emergencies where there is a risk of the patient harming himself/herself or others. c. using the least restrictive method. 2. Protect the patient and preserve the patient's rights, dignity and well being during restraint use by: a. respecting the patient as an individual; b. maintaining a clean and safe environment; ...d. maintaining the patient's modesty, preventing visibility to others, and maintaining comfortable body temperature is maintained. 3. Provide for safe application and removal of the restraint by qualified staff. 4. Monitor and meet the patient's needs while in restraints. 5. Re-assess and encourage release of restraints as soon as possible. ...Restraints will be used only in situations where the patient is demonstrating observable behaviors that indicate he/she is at risk of injuring himself/herself or others. Restraints are not to be used for punishment, coercion, discipline, or retaliation of the patient or for staff convenience. This policy does not apply to devices....used by law enforcement officials although the standards of care stated within this document may be applicable. ...PROCEDURES: ASSESSMENT OF RISK FACTORS, INTERVENTIONS AND ALTERNATIVES TO RESTRAINT USE: A comprehensive assessment of the patient must determine that the risks associated with the use of the restraint are outweighed by the risk of not using it. ...Attempts should be made to evaluate and use the following interventions/alternatives when possible and in response to the patient's assessed needs: *Monitoring: 1. Companionship; staff or family stay with patient 2. Room near or visible from nursing station 3. Close, frequent observation ...*Environmental Measures: ...5. Room/halls clear of obstacles such as excess equipment ...Regular toileting: 1. Establish consistent toileting schedule for patient. ...CLINICAL JUSTIFICATION FOR USE OF RESTRAINT AND/OR SECLUSION: When clinically indicated, the restraint procedure is implemented by the RN who is trained in restraint and/or seclusion techniques upon a physician's/LIP's order. Unless there is an immediate and overriding concern for safety, the restraint procedure is utilized only after all alternatives, less restrictive treatment interventions have been tried without success. Prior to implementation of any restraint, care team members will confer to determine that appropriate alternative measures have been attempted. Using the decision flowcharts for patient behaviors and alternatives for use of restraint, clinical assessment and utilization of restraint should be based on patient's behavior that may place the patient or others at risk for harm. Situations in which restraints are clinically justified include: *Threatens placement and/or patiency of necessary therapeutic lines/tubs, interfering with necessary medical treatment, and appropriate alternative measures have been attempted. ...*Unable to follow directions to avoid self-injury, and appropriate protective, alternative measures have been attempted. *Vulnerable patient populations, such as Pediatrics, who are cognitively or physically limited, are at a greater risk for injury Great caution should be utilized before initiating restraint use. LEAST RESTRICTIVE RESTRAINT/SAFE APPLICATION: Assessment and reassessment processes should include the appropriateness of the choice of restraint and/or seclusion. Physical restraints will be loosened periodically to evaluate skin integrity and circulation while the patient is in restraints. The types of restraint devices available within this facility and how to apply safely is as follows: ...2. Limb Restraints 1-->2-->3-->4-point ...5. Seclusion - Seclusion is the involuntary confinement of a patient alone in a room or area from which the patient is physically prevented from leaving. Seclusion may only be used for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, staff member, or others. Seclusion is not a patient physically restrained alone in an unlocked room... ALTERNATIVE THERAPY: Prior to physically restraining a patient, restraint-free interventions such as (but not limited to) the following are attempted: *Provide safe environment, i.e., bed in low position, clutter free environment ...Enhanced observation ...*Sitter... PROCEDURE FOR USE OF RESTRAINT: Initiation and Renewal of Orders Standing orders, protocols, and/or PRN orders are not permitted. When initiating the use of a restraint, the appropriate restraint physician's order form (Nonviolent or Violent/Self Destructive) must be completed and placed on the chart within 30 minutes. This original order is time-limited based on type of restraint and age of patient. When use of restraints is contemplated, a physician/LIP or RN who has been trained in restraint application must document a face-to-face assessment prior to applying restraints, and document the need for restraint within the 1 hour time frame. The physician's/LIP's order must specify: *the restraint type *the justification for the restraint *date and time ordered *duration ...The in-person evaluation, conducted within one hour of the initiation of restraint or seclusion for the management of violent or self-destructive behavior that jeopardizes the physical safety of the patient, staff or others, includes the following: *an evaluation of the patient's immediate situation *the patient's reaction to the restraint *the patient's medical and behavioral condition *the need to continue or terminate the restraint or seclusion ...The Nonviolent Restraint Physician's Orders: Orders for nonviolent restraints must be renewed each calendar day by the patient's attending physician or other designated LIP based on his or her examination of the patient. It is not necessary for the renewal to be completed within a 24-hour time-frame as the physician can re-evaluate the patient and need for non-violent/self-destructive restraints during routine rounds. If restraints for nonviolent behavior purposes are anticipated to be continued beyond the maximum time limit of the order, a restraint renewal sticker is placed on the physician order form and must be completed by the LIP before the original order expires. Its use is based on his or her face-to-face examination of the patient. For Violent/Self-Destructive Restraints [V/SD] A physician/LIP or trained RN must document a face-to-face assessment within 1 hour of implementation of restraint or seclusion. The 1-hour face-to-face evaluation includes both a physical and behavioral assessment of the patient that must be conducted by a qualified practitioner within the scope of their practice. An evaluation of the patient's medical condition would include a complete review of systems assessment, behavioral assessment, as well as review and assessment of the patient's history, drugs and medications, most recent lab results, etc. The purpose is to complete a comprehensive review of the patient's condition to determine if other factors, such as drug or medication interactions, electrolyte imbalances, hypoxia, sepsis, etc., are contributing to the patient's violent or self-destructive behavior. During the face-to-face assessment, the qualified practitioner will evaluate the patient's immediate situation, the patient's reaction to the intervention, the patient's medical and behavioral condition; and the need to continue or terminate the restraint or seclusion. The time limit for Violent/Self-Destructive Restraints is: *4 hours for adults (18 years of age or older) *2 hours for children (ages 9-17) *1 hour for children under age of 9 ...All patients who are in restraints must be continuously monitored and reassessed for the need to continue restraint by a qualified registered nurse (RN). ...When the order for restraints expires, a qualified, trained individual (who has been authorized by the organization to perform this function) will conduct an in-person assessment. If the patient is not ready for release from restraints, the authorized staff member will re-evaluate the efficacy of the patient's treatment plan and revise accordingly. the physician/LIP responsible for the patient's ongoing care will then be notified and a telephone order will be obtained and a new restraint physician order form will be placed on the chart for completion by the LIP. When the authorized, qualified staff member other than the physician/LIP continues restraints based on a new telephone order by the physician/LIP, the physician/LIP will re-evaluate the patient i.e. face-to-face assessment at least every 24 hours for adults, 2 hours for ages 9-17 and after 1 hour for children under age of 9 years for nonviolent restraints. If restraints are to be continued, a new time-limited order for restraints will be obtained from the physician/LIP. For Violent/Self Destructive restraints, a face-to-face re-evaluation by the physician/LIP is required after 4 hours for adult patients, after 2 hours for children ages 9-17 and after 1 hour for children under age 9. Seclusion guidelines 1. Individuals placed in seclusion must have a protected, private observable environment that safe guards their dignity and well-being. 2. The decision to seclude may be made by a trained RN in an emergency situation in which the patient exhibits violent, self-destructive behavior, when the physician is not available, after conducting a face-to-face assessment of the individual to determine whether the behavior requires seclusion. A physician or other LIP must see and evaluate the need for seclusion within one hour after the intervention is initiated. ...4. The patient who is simultaneously restrained and secluded is continually monitored by trained staff either in-person or through the use of both video and audio equipment that is in close proximity to the patient. 5. Staff must monitor an individual placed in seclusion and document findings at a minimum of every 15 minutes. 6. Articles that might be used to inflict self-injury must be removed prior to placing in seclusion. ...8. If an individual falls asleep in seclusion, the door must be unlocked and opened within the nearest fifteen minute period monitoring. If the door is not unlocked, clinical justification must be documented in the patient's clinical record. Upon awakening, the patient must be re-evaluated by a RN or the physician upon awakening for continued release without regard to how long the individual was asleep or whether the maximum length of time prescribed in the order has expired. ...Discontinuing Restraint Once restraint is applied or initiated, the patient should be monitored and evaluated for the continued need of the intervention and the continued appropriateness of the type of intervention. ...The restraint should be discontinued as soon as the patient meets the behavior criteria for its discontinuation. The assessment of the continued need for restraint to determine early release should be documented at a minimum of every two hours or more often as the patient's condition improves. ...MONITORING, ASSESSING, AND CARE OF THE PATIENT IN RESTRAINTS: When restraints are used there is an increased need for patient monitoring and assessment to assure patient safety, that the less restrictive methods are used when possible, and that restraint is discontinued as soon as possible. Immediately after restraints are applied an assessment should be made to ensure that the restraints were properly and safely applied so as to not cause the patient harm or pain. Documentation should include this assessment as well as the patient's response, any adjustments made. The frequency of monitoring the patient must be made on an individual basis, which includes a rationale that reflects consideration of the individual patient's medical needs and health status. The assessment includes, as appropriate to the type of restraint used: *signs of injury associated with the restraints *nutrition/hydration *circulation and range of motion in the extremities *vital signs *hygiene and elimination *physical and psychological status and comfort (i.e. skin integrity, comfortable body temperature, the patient's dignity, mental status, and emotional well being) *readiness for release from restraints *patient's understanding of the reasons for restraint and requirements for release ...PATIENT/FAMILY EDUCATION: Restraint procedures should be performed in a manner that does not violate the patient's rights. ...For Non-Violent restraints, reassessment and documentation is required at least every 2 hours and for Violent/Self-Destructive restraints, it is required every 15 minutes. DOCUMENTATION: The medical record should document: *that the patient and/or family was informed of the organization's policy on the use of restraints; *any medical condition or any physical disability that would place the patient at greater risk during restraints/seclusion; *any history of sexual or physical abuse that would place the patient at grater psychological risk during restraint/seclusion. Documentation within the patient's record should indicate a clear progression in how techniques were implemented with the less intrusive restrictive intervention attempted or considered prior to the introduction of more restricted measure. When a restraint is initiated, the order must be documented immediately upon initiation. If the order for restraint is note initiated by the treating physician, the order must be followed by consultation with the patient's attending physician as soon as possible. ...Each episode of restraint/seclusion use is to be recorded in the medical record. Documentation will include: *date restraint applied *time restraint applied *type of Restraint (non-violent or violent/self destructive) *restraint device (soft, mitten, vest, geri-chair, etc.) *safe application verified *level of consciousness *safety/rights/dignity maintained verified *observed restraints appropriately intact *behavior during restraints *vital signs taken *free from injury associated with restraint *skin under/around restraint intact * range of motion done *circulation distal to restraint verified *offered nutrition/hydration *offered assistance with toileting/hygiene *offered comfort measures *the circumstances that led to restraint or seclusion use *consideration or failure of non-physical interventions including alternatives attempted and successful *the rationale for the type of physical intervention selected *notification of the patient's family/significant other, when appropriate *patient's response and any changes made as a result of the restraints *each telephone order received from a physician/LIP * debriefing of the patient with staff *any injuries that are sustained and treatment received from these injuries *any deaths. DISCONTINUING RESTRAINT DOCUMENTATION GUIDELINES *Criteria for restraint release met *Date restraint discontinued *Time restraint discontinued *Restraint debriefing when applicable for behavior (violent/self-destructive) MODIFICATION TO PATIENT'S PLAN OF CARE: The plan of care should clearly reflect a loop of assessment, intervention, evaluation and re-intervention. Restraint use must be in accordance with a written modification to the patient's plan of care..."

1. Observation during ED tour on 01/14/2015 at 1427 of exam room #17, revealed the room was located across from the nursing station. Observation revealed the room had a sliding glass door. Observation revealed a male patient (Patient #14) wearing green disposable scrubs and sitting on the end of the stretcher leaning over a bedside table. Observation revealed the stretcher's two side rails were up and in the locked position. Observation revealed the patient was alert, calm, and cooperative. Observation revealed the patient's right leg/ankle was chained to the stretcher's frame with a metal shackle/cuff (restraint). Observation revealed the patient did not exhibit any violent or self-destructive behaviors. Observation revealed the patient was in the exam room alone and without direct supervision of a LEO. At 1433, observation revealed Patient #14 stood up off the end of the stretcher and pivoted around to the side of the stretcher without difficulty or assistance. At 1434, observation revealed XYZ County Sheriff Deputy (CSD) #1 was sitting behind the nursing station in a cubical. Observation revealed the cubical was on the opposite side of the nursing station, away from exam room #17. Observation revealed CSD #1 stood up and exited the cubical and walked down the hallway on the opposite side of the nursing station, away from exam room #17 and exited the emergency department treatment area through a set of double doors. Observation revealed Patient #14 was alone in exam room #17 unsupervised by a LEO. At 1436, observation revealed CSD #1 returned to the cubical in the nursing station and sat down. Observations from 1427 to 1500 failed to observe any violent or self-destructive behaviors exhibited by Patient #14 while being restrained in exam room #17.

Open medical record review on 01/14/2015 revealed Patient #14, a [AGE] year old male presented to the hospital's ED on 01/13/2015 at 1820 accompanied by Law Enforcement under IVC petition. Review revealed the patient's chief complaint was IVC-Crisis Evaluation Referral. Review of triage nurse documentation at 1827 revealed "IVC, per caregiver pt (patient) with bizarre behavior, pt walking around showing gentials [sic], pt endorses auditory hallucinations, pt with rambling thoughts in triage, pt states he will only hurt someone if they try to hurt him." Review of triage assessment documentation revealed the patient was alert, oriented x 3 (person, place, time) and anxious. Review revealed the patient was evaluated by a physician at 1908. Review revealed a chief complaint of being agitated and exposing genitals. Review revealed the patient was assessed as no acute distress, awake and alert, slightly agitated, pressured speech, and directable. Review revealed the patient was "cooperative." Review of a "Findings and Custody Order Involuntary Commitment" revealed the order was signed on 01/13/2015 at 1541 by a Magistrate. Review revealed "The Court finds from the petition in the above matter that there are reasonable grounds to believe that the facts alleged in the petition are true and that the respondent (Patient #14) is probably: [X] 1. mentally ill and dangerous to self or others or mentally ill and in need of treatment in order to prevent further disability or deterioration that would predictably result in dangerousness. ..." Review of an "Examination and Recommendation to Determine Necessity for Involuntary Commitment" form dated 01/13/2015 at 2345 revealed "Description of Findings" with "...presenting for agitation, exposing himself inappropriately to others. On evaluation, pt is disorganized with pressured speech. Oriented to location but not situation. Is currently a danger to himself due to psychosis." Review of nursing documentation at 2235 revealed "Resting quietly in bed. No aggressive behaviors, no self-injurious behavior. ..." At 1215 (01/14/2015) "...Pt unshackled while bed was exchanged." At 1330 "Pt sitting at end of bed. No c/o voiced. No distress noted." At 1500 "Pt sitting on bed c (with) no distress noted." At 1845 "Pt transported to (hospital name)....ambulated to police care no distress noted." Review of "Suicide Precautions Flow sheet" documentation on 01/13/2015 from 1900 to 2300 and 01/14/2015 from 0715 to 1845 revealed the patient's behavior was documented by staff as calm or cooperative. Review revealed no documentation the patient was violent or aggressive. Review revealed on 01/14/2015 at 1430, 1445, and 1500 (corresponding timeframe to Surveyor's observation [1427-1500] of the patient cuffed/shackled to the stretcher) as being cooperative. Record review failed to reveal any available documentation Patient #14 exhibited violent or self-destructive behaviors necessitating the need for restraint use while hospitalized from [DATE] at 1820 through discharge on 01/14/2015 at 1845. Further record review failed to reveal documentation of ongoing monitoring and assessment of the patient at least every 15 minutes for violent/self-destructive restraint or every two hours for non-violent restraint (as appropriate to the type of restraint used) for one or more of the following: signs of injury associated with the restraints, nutrition/hydration, circulation and range of motion in the extremities, vital signs, hygiene and elimination, physical and psychological status and comfort (i.e. skin integrity, comfortable body temperature, the patient's dignity, mental status, and emotional well being), readiness for release from restraints, patient's understanding of the reasons for restraint and requirements for release, per hospital policy.

Interview on 01/13/2015 at 1107 during ED tour with Charge Nurse #1 revealed the only approved restraints used in the ED by nursing staff are "soft limb restraints." Interview revealed "only the Sheriff and Police Departments use handcuffs and shackles with IVC patients." Interview revealed the nurse is responsible for monitoring and assessing the patient when in handcuffs or shackles. Interview revealed the nursing staff is not responsible for applying the handcuffs or shackles.

Interview on 01/14/2015 at 1442 with CSD #1 revealed he was a Deputy Sheriff with the XYZ County Sheriff's Department. Interview revealed he was present in the ED for a "10-73" (mental subject). Interview revealed the patient (#14) in exam room #17 was under IVC. Interview revealed the patient was brought to the ED on 01/13/2015. Interview revealed he relieved the previous Deputy this morning (01/14/2015) at shift change. Interview revealed the previous Deputy placed the patient into "ankle shackles." Interview revealed the "officer makes the decision wither or not the patient needs to be handcuffed or shackled." Interview revealed Patient #14 was not going to jail and was not under arrest. Interview revealed he (CSD #1) was on standby until a mental health facility could be found for the patient. Interview revealed because the patient was in his custody, he was responsible for any of the patient's actions. Interview revealed when the patient complains the cuffs/shackles are too tight or hurting, he will use 2-3 fingers to check to see if the cuffs/shackles are too tight. Interview revealed there was no set schedule for periodically removing the cuffs/shackles or checking for tightness. Interview revealed the "patient lets me know if they are too tight." Interview revealed if the patient needed to go to the restroom, the cuffs/shackles are removed. Interview revealed he does not check pulses or skin for circulation. Interview revealed the nurse is responsible for taking care of the patient's medical needs. Interview revealed he does not document in the patients ED medical record.

Interview on 01/15/2015 at 1015 with the ED Medical Director revealed he spoke with a police officer with the ABC City Police Department while in the ED. Interview revealed the police officer stated the Chief of Police had determined that the IVC patients were in the custody of the police officer and that it was Departmental policy for all IVC patients to be placed into handcuffs or shackles while in the ED. Interview revealed "we can't control the police putting the patients in custody." Interview revealed "we can control the monitoring of the patients." The interview revealed " we have been trying to work through this for the past 9 months with Chief of Police."

Interview on 01/15/2015 at 1235 with the ED Nursing Director revealed patients brought into the ED under IVC or who are placed under IVC while in the ED were placed into "forensic" restraints (handcuffs or shackles) by the law enforcement officers. Interview revealed the ED staff did not view the placement of IVC patients in handcuffs or shackles as a restraint, because they were in the custody of law enforcement. Interview revealed there would not be any documentation of monitoring and assessment every 15 minutes (for violent self-destructive behavior) and/or 2 hours (for non-violent behavior), because the handcuffs and shackles were not considered a restrictive intervention by ED staff. Interview revealed the ED staff did not follow the hospital's Restraint of Patient policy for monitoring Patient #14 while he was restrained in the ED with metal cuffs/shackles placed by a law enforcement officer.

2. Observation during ED tour on 01/14/2015 at 1438 of exam room #5, revealed the room was located diagonally across from the nursing station. Observation revealed the room had a wood door. Observation revealed a female patient (Patient #16) wearing green disposable scrubs and laying on her left side on the stretcher, watching television. Observation revealed the stretcher's two side rails were up and in the locked position. Observation revealed the patient was alert, calm, and cooperative. Observation revealed the patient's left wrist was chained to the stretcher's frame with a metal cuff/shackle (restraint). Observation revealed the patient did not exhibit any violent or self-destructive behaviors. Observation revealed the patient was in the exam room alone and without direct supervision of a LEO. Observation revealed an ABC City Police Department officer was sitting behind the nursing station in a cubical, reading a magazine. Observations from 1438 to 1500 failed to observe any violent or self-destructive behaviors exhibited by Patient #16 while being restrained in exam room #5.

Open medical record review on 01/15/2015 for Patient #16 revealed an [AGE] year old female presented to the Hospital's ED on 01/13/2015 at 1726 for "potential drug overdose." Review revealed the patient was triaged by a RN at 1732 and was assessed by a ED Physician at 1734. Review revealed the patient was assessed at 1912 by a mobile crisis worker. Review revealed on 01/14/2015 at 0050, the patient was IVC for being mentally ill and dangerous to self and others. Review revealed at 0200 and 0400, the patient's behavior was documented as asleep with parent and LEO at bedside. Review revealed from 0600 to 01/15/2015 at 0515, the patient's behavior was documented as asleep, tearful, and resting quietly in bed, resting in bed with eyes closed and laying in bed with eyes closed. Review revealed at 0536, the patient requested the "shackle" (restraint) be loosened and the hospital staff informed the LEO. Review revealed at 0725, the patient behavior was documented as alert and oriented with right lower extremity "cuffed" (restraint) to bed frame. Review revealed at 0835, the patient was transferred to a Psychiatric hospital. Record review failed to reveal any available documentation Patient #16 exhibited violent or self-destructive behaviors necessitating the need for restraint use while hospitalized from [DATE] at 1726 through discharge on 01/15/2015 at 0835.

Interview on 01/13/2015 at 1107 during ED tour with Charge Nurse #1 revealed the only approved restraints used in the ED by nursing staff are "soft limb restraints." Interview revealed "only the Sheriff and Police Departments use handcuffs and shackles with IVC patients." Interview revealed the nurse is responsible for monitoring and assessing the patient when in handcuffs or shackles. Interview revealed the nursing staff is not responsible for applying the handcuffs or shackles.

Interview with ABC Police Officer #1 on 01/14/2015 at 1435 revealed he was responsible for 3 patients under IVC in the ED at this time. The interview revealed he stations himself at an area in the corner. The interview revealed he can observe the patient in the seclusion room and the patient in room #5. The interview revealed Officer # 1 was not allowed to answer any further questions. The interview revealed a phone number to two Lieutenant at the City Police Department if further questions needed to be asked.

Interview on 01/15/2015 at 1015 with the ED Medical Director revealed he spoke with a police officer with the ABC City Police Department while in the ED. Interview revealed the police officer stated the Chief of Police had determined that the IVC patients were in the custody of the police officer and that it was Departmental policy for all IVC patients to be placed into handcuffs or shackles while in the ED. Interview revealed "we can't control the police putting the patients in custody." Interview revealed "we can control the monitoring of the patients." The interview revealed " we have been trying to work through this for the past 9 months with Chief of Police."

Interview on 01/15/2015 at 1235 with the ED Nursing Director revealed patients brought into the ED under IVC or who are placed under IVC while in the ED were placed into "forensic" restraints (handcuffs or shackles) by the law enforcement officers. Interview revealed the ED staff did not view the placement of IVC patients in handcuffs or shackles as a restraint, because they were in the custody of law enforcement. Interview revealed there would not be any documentation of monitoring and assessment every 15 minutes (f
VIOLATION: FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE Tag No: A0724
Based on hospital policy reviews, observations during Emergency Department (ED) tour, and staff interviews the hospital's ED staff failed to maintain the facilities, supplies, and equipment in an manner to ensure an acceptable level of safety and quality for 1 of 1 ED toured.

The findings include:

Review of current hospital policy "Compressed Gas and Oxygen Use, EOC-69" revised 10/2014, revealed "PROCEDURE: *General Standards ...*Cylinders must be secured at all times so they cannot fall. ...*Oxygen Use: *Oxygen and other gases are potentially dangerous. Special safety precautions shall be followed at all times while using or storing oxygen. *Ensure cylinders are secure on rack and never hand anything on cylinder. ...*Store oxygen cylinders upright and secured. *Ensure oxygen cylinders are secured in a dedicated carrier..."

Review of current hospital policy "Refrigerators and Freezers: Care of, PC 19" revised 02/2012, revealed "PURPOSE: To insure that refrigerators and freezers are clean, contents properly stored, and the temperature monitored. POLICY: 1. Patient care refrigerators/freezers should be cleaned regularly and as necessary for spills by the nursing staff. ...GUIDELINES CONTENTS: 1. Patient food refrigerators should contain only food that has been properly wrapped. Food items designated for a specific patient should be dated and labeled with that patient's name. ..."

Review of current hospital policy "Emergency Department Infection Prevention Guidelines, IC-103" revised 12/2011, revealed "...Refrigerators All refrigerators will be cleaned when soiled. ...Any food stored for patients should be in containers and labeled with the name of the patient and discarded in 24 hours. ...Housekeeping All work surfaces and equipment should be cleaned with a disinfectant solution daily and when visibly soiled. Routine daily cleaning of floors is required and walls routinely or when visibly soiled. ...The medication preparation area should be freeze of clutter and the countertop wiped with disinfectant cleaner once each shift. ..."

Review of current hospital policy "...Infection Prevention Guidelines, IC-113" revised 01/2014, revealed "...ENVIRONMENT, EQUIPMENT AND CLEANING: ...Medical Supplies Staff should check supplies before using and routinely for expiration dates. Return out of date supplies to Materials Management for replacements. ..."

Observations during tour of the ED on 01/13/2015 from 1107 to 1230 revealed the following:
1. In Exam (Trauma) Room #2 - Observed one (1) 8.5 French Percutaneous Sheath Introducer Kit with an expiration date of 10/2014 (expired) and one (1) pneumothorax kit with an expiration date of 06/2014 (expired), stored in cabinet. Observed a portable oxygen cylinder containing approximately 900 Liters of oxygen, standing upright on the floor without being secured in a manner to prevent fall.
2. In Clean Supply/Storage Room - Observed bulk linen stored on multiple shelves, uncovered. Observation revealed the room was not a dedicated linen storage room. Observation revealed other clean medical supplies and equipment stored on track shelves.
3. Patient Refrigerator/Freezer - Observed four (4) salads and three (3) fruit cobblers stored in refrigerator compartment, not dated or labeled. Observed dried liquid spills on the inside refrigerator surfaces. Observed brown food particles spilled on the inside surfaces of the freezer compartment.
4. Patient Microwave - Observed food particles and dried liquids spilled on inside surfaces of the microwave.
5. In Medication Room - Observed heavy dust accumulation on outer surfaces of the automated medication dispensing system (Pyxis). Observed dried liquid splatter on the countertop surfaces, outer cabinet doors surfaces, outer medication refrigerator door surface, and the floor.

Interview during ED tour with ED Nursing Director #1 and ED Charge Nurse #1 revealed the above observations. Interview revealed nursing staff check the trauma room two times per day (morning and evening) to ensure supplies are present. Interview revealed nursing staff should be checking supplies for expiration dates and expired supplies should be removed and not available for patient care. Interview revealed the oxygen cylinder should not be stored standing upright and unsecured, the cylinder should be stored in a rack. Interview revealed the clean supply/storage room is used to store medical supplies and linens. Interview revealed the linen is kept uncovered. Interview revealed food items should not be placed into the refrigerator without being dated and labeled. Interview revealed it is unknown how long the salads and fruit cobblers had been in the refrigerator. Interview revealed dietary staff are responsible for cleaning the inside of the refrigerator/freezer. Interview revealed it is unknown when the refrigerator/freezer was last cleaned. Interview revealed there is not a set schedule for cleaning the microwave. Interview revealed nursing staff are responsible for cleaning the microwave when they find it dirty. Interview revealed it is unknown when the microwave was last cleaned. Interview revealed nursing staff are responsible for cleaning the counter surfaces in the medication room and house keeping is responsible for dusting and mopping the floor. Interview revealed there is not a set schedule for cleaning the medication room. Interview revealed it is unknown when the medication room surfaces and floors were last cleaned. Interview revealed the ED staff failed to follow hospital policies.
VIOLATION: EMERGENCY SERVICES Tag No: A1100
Based upon hospital policy and procedure reviews, observations during tours, medical record reviews, Law Enforcement Officer (LEO) interviews, staff and physician interviews, the hospital failed to meet the emergency needs of behavioral health patients in accordance with the hospital's policy and procedures.

The findings include:

1. The hospital's Emergency nursing staff failed to provide ongoing assessment and monitoring of the condition of a patient during restraint or seclusion for 6 of 6 emergency department (ED) patients (#14, #16, #13, #17 #12, #9) under involuntary commitment (IVC).

~cross refer to 482.55(a)(3) Standard - Tag A1104.
VIOLATION: EMERGENCY SERVICES POLICIES Tag No: A1104
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based upon hospital policy and procedure reviews, observations during tours, medical record reviews, Law Enforcement Officer (LEO) interviews, staff and physician interviews, the hospital's Emergency nursing staff failed to provide ongoing assessment and monitoring of the condition of a patient during restraint or seclusion for 6 of 6 emergency department (ED) patients (#14, #16, #13, #17 #12, #9) under involuntary commitment (IVC).

The findings include:

Review of current hospital policy "Restraint of Patients, PC 17", revised 12/2014, revealed "PURPOSE: The use of restraints is a therapeutic intervention implemented to prevent the patient from injuring himself/herself or from injuring others. The decision to use a restraint is driven by a comprehensive individual assessment. This document is used to provide consistent guidelines for the safe use of chemical and physical restraints and seclusion, if alternatives, as determined by an interdisciplinary team, have proven to be clinically ineffective to provide a safe environment for the patient. ...DEFINITIONS: Restraint - is the direct application of physical force to a patient, with or without the patient's permission, to restrict his or her freedom of movement. The physical force may be human, mechanical devices, or a combination thereof. Physical Restraints - any manual method or physical/mechanical device, material or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely. ...Restraint to Promote Medical Recovery (non-violent): refers to the use of restraints in those patients who require various medically essential therapies while hospitalized and who demonstrate a state of confusion or altered cognition that puts those therapies at risk OR those patients who require management of non-psychiatric behaviors that put them at risk for injury. Restraints for Violent or Self-Destructive Behavior: refers to the use of restraints in those patients who require management of violent or self-destructive behavior towards themselves or others (including caregivers or other patients) or, who require physical restraint to manage suicidal or homicidal behaviors in ANY setting. ...Restrictive Devices Applied by Law Enforcement Officials - handcuffs and other restrictive devices applied by law enforcement officials for custody, detention, and public safety reasons and is not involved in the provision of health care; no considered restraints. ...Seclusion - seclusion is the involuntary confinement of a patient alone in a room or area from which the patient is physically prevented from leaving. Seclusion may only be used for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others. The following interventions are not considered seclusion: 1. a patient physically restrained alone in an unlocked room. ...POLICY: It is the policy of (Hospital name) Medical Center to: 1. Prevent, reduce and eliminate the use of restraints by: a. preventing emergencies that have the potential to lead to the use of restraints, b. limiting the use of restraints to emergencies where there is a risk of the patient harming himself/herself or others. c. using the least restrictive method. 2. Protect the patient and preserve the patient's rights, dignity and well being during restraint use by: a. respecting the patient as an individual; b. maintaining a clean and safe environment; ...d. maintaining the patient's modesty, preventing visibility to others, and maintaining comfortable body temperature is maintained. 3. Provide for safe application and removal of the restraint by qualified staff. 4. Monitor and meet the patient's needs while in restraints. 5. Re-assess and encourage release of restraints as soon as possible. ...Restraints will be used only in situations where the patient is demonstrating observable behaviors that indicate he/she is at risk of injuring himself/herself or others. Restraints are not to be used for punishment, coercion, discipline, or retaliation of the patient or for staff convenience. This policy does not apply to devices....used by law enforcement officials although the standards of care stated within this document may be applicable. ...PROCEDURES: ASSESSMENT OF RISK FACTORS, INTERVENTIONS AND ALTERNATIVES TO RESTRAINT USE: A comprehensive assessment of the patient must determine that the risks associated with the use of the restraint are outweighed by the risk of not using it. ...Attempts should be made to evaluate and use the following interventions/alternatives when possible and in response to the patient's assessed needs: *Monitoring: 1. Companionship; staff or family stay with patient 2. Room near or visible from nursing station 3. Close, frequent observation ...*Environmental Measures: ...5. Room/halls clear of obstacles such as excess equipment ...Regular toileting: 1. Establish consistent toileting schedule for patient. ...CLINICAL JUSTIFICATION FOR USE OF RESTRAINT AND/OR SECLUSION: When clinically indicated, the restraint procedure is implemented by the RN who is trained in restraint and/or seclusion techniques upon a physician's/LIP's order. Unless there is an immediate and overriding concern for safety, the restraint procedure is utilized only after all alternatives, less restrictive treatment interventions have been tried without success. Prior to implementation of any restraint, care team members will confer to determine that appropriate alternative measures have been attempted. Using the decision flowcharts for patient behaviors and alternatives for use of restraint, clinical assessment and utilization of restraint should be based on patient's behavior that may place the patient or others at risk for harm. Situations in which restraints are clinically justified include: *Threatens placement and/or patiency of necessary therapeutic lines/tubs, interfering with necessary medical treatment, and appropriate alternative measures have been attempted. ...*Unable to follow directions to avoid self-injury, and appropriate protective, alternative measures have been attempted. *Vulnerable patient populations, such as Pediatrics, who are cognitively or physically limited, are at a greater risk for injury Great caution should be utilized before initiating restraint use. LEAST RESTRICTIVE RESTRAINT/SAFE APPLICATION: Assessment and reassessment processes should include the appropriateness of the choice of restraint and/or seclusion. Physical restraints will be loosened periodically to evaluate skin integrity and circulation while the patient is in restraints. The types of restraint devices available within this facility and how to apply safely is as follows: ...2. Limb Restraints 1-->2-->3-->4-point ...5. Seclusion - Seclusion is the involuntary confinement of a patient alone in a room or area from which the patient is physically prevented from leaving. Seclusion may only be used for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, staff member, or others. Seclusion is not a patient physically restrained alone in an unlocked room... ALTERNATIVE THERAPY: Prior to physically restraining a patient, restraint-free interventions such as (but not limited to) the following are attempted: *Provide safe environment, i.e., bed in low position, clutter free environment ...Enhanced observation ...*Sitter... PROCEDURE FOR USE OF RESTRAINT: Initiation and Renewal of Orders Standing orders, protocols, and/or PRN orders are not permitted. When initiating the use of a restraint, the appropriate restraint physician's order form (Nonviolent or Violent/Self Destructive) must be completed and placed on the chart within 30 minutes. This original order is time-limited based on type of restraint and age of patient. When use of restraints is contemplated, a physician/LIP or RN who has been trained in restraint application must document a face-to-face assessment prior to applying restraints, and document the need for restraint within the 1 hour time frame. The physician's/LIP's order must specify: *the restraint type *the justification for the restraint *date and time ordered *duration ...The in-person evaluation, conducted within one hour of the initiation of restraint or seclusion for the management of violent or self-destructive behavior that jeopardizes the physical safety of the patient, staff or others, includes the following: *an evaluation of the patient's immediate situation *the patient's reaction to the restraint *the patient's medical and behavioral condition *the need to continue or terminate the restraint or seclusion ...The Nonviolent Restraint Physician's Orders: Orders for nonviolent restraints must be renewed each calendar day by the patient's attending physician or other designated LIP based on his or her examination of the patient. It is not necessary for the renewal to be completed within a 24-hour time-frame as the physician can re-evaluate the patient and need for non-violent/self-destructive restraints during routine rounds. If restraints for nonviolent behavior purposes are anticipated to be continued beyond the maximum time limit of the order, a restraint renewal sticker is placed on the physician order form and must be completed by the LIP before the original order expires. Its use is based on his or her face-to-face examination of the patient. For Violent/Self-Destructive Restraints [V/SD] A physician/LIP or trained RN must document a face-to-face assessment within 1 hour of implementation of restraint or seclusion. The 1-hour face-to-face evaluation includes both a physical and behavioral assessment of the patient that must be conducted by a qualified practitioner within the scope of their practice. An evaluation of the patient's medical condition would include a complete review of systems assessment, behavioral assessment, as well as review and assessment of the patient's history, drugs and medications, most recent lab results, etc. The purpose is to complete a comprehensive review of the patient's condition to determine if other factors, such as drug or medication interactions, electrolyte imbalances, hypoxia, sepsis, etc., are contributing to the patient's violent or self-destructive behavior. During the face-to-face assessment, the qualified practitioner will evaluate the patient's immediate situation, the patient's reaction to the intervention, the patient's medical and behavioral condition; and the need to continue or terminate the restraint or seclusion. The time limit for Violent/Self-Destructive Restraints is: *4 hours for adults (18 years of age or older) *2 hours for children (ages 9-17) *1 hour for children under age of 9 ...All patients who are in restraints must be continuously monitored and reassessed for the need to continue restraint by a qualified registered nurse (RN). ...When the order for restraints expires, a qualified, trained individual (who has been authorized by the organization to perform this function) will conduct an in-person assessment. If the patient is not ready for release from restraints, the authorized staff member will re-evaluate the efficacy of the patient's treatment plan and revise accordingly. the physician/LIP responsible for the patient's ongoing care will then be notified and a telephone order will be obtained and a new restraint physician order form will be placed on the chart for completion by the LIP. When the authorized, qualified staff member other than the physician/LIP continues restraints based on a new telephone order by the physician/LIP, the physician/LIP will re-evaluate the patient i.e. face-to-face assessment at least every 24 hours for adults, 2 hours for ages 9-17 and after 1 hour for children under age of 9 years for nonviolent restraints. If restraints are to be continued, a new time-limited order for restraints will be obtained from the physician/LIP. For Violent/Self Destructive restraints, a face-to-face re-evaluation by the physician/LIP is required after 4 hours for adult patients, after 2 hours for children ages 9-17 and after 1 hour for children under age 9. Seclusion guidelines 1. Individuals placed in seclusion must have a protected, private observable environment that safe guards their dignity and well-being. 2. The decision to seclude may be made by a trained RN in an emergency situation in which the patient exhibits violent, self-destructive behavior, when the physician is not available, after conducting a face-to-face assessment of the individual to determine whether the behavior requires seclusion. A physician or other LIP must see and evaluate the need for seclusion within one hour after the intervention is initiated. ...4. The patient who is simultaneously restrained and secluded is continually monitored by trained staff either in-person or through the use of both video and audio equipment that is in close proximity to the patient. 5. Staff must monitor an individual placed in seclusion and document findings at a minimum of every 15 minutes. 6. Articles that might be used to inflict self-injury must be removed prior to placing in seclusion. ...8. If an individual falls asleep in seclusion, the door must be unlocked and opened within the nearest fifteen minute period monitoring. If the door is not unlocked, clinical justification must be documented in the patient's clinical record. Upon awakening, the patient must be re-evaluated by a RN or the physician upon awakening for continued release without regard to how long the individual was asleep or whether the maximum length of time prescribed in the order has expired. ...Discontinuing Restraint Once restraint is applied or initiated, the patient should be monitored and evaluated for the continued need of the intervention and the continued appropriateness of the type of intervention. ...The restraint should be discontinued as soon as the patient meets the behavior criteria for its discontinuation. The assessment of the continued need for restraint to determine early release should be documented at a minimum of every two hours or more often as the patient's condition improves. ...MONITORING, ASSESSING, AND CARE OF THE PATIENT IN RESTRAINTS: When restraints are used there is an increased need for patient monitoring and assessment to assure patient safety, that the less restrictive methods are used when possible, and that restraint is discontinued as soon as possible. Immediately after restraints are applied an assessment should be made to ensure that the restraints were properly and safely applied so as to not cause the patient harm or pain. Documentation should include this assessment as well as the patient's response, any adjustments made. The frequency of monitoring the patient must be made on an individual basis, which includes a rationale that reflects consideration of the individual patient's medical needs and health status. The assessment includes, as appropriate to the type of restraint used: *signs of injury associated with the restraints *nutrition/hydration *circulation and range of motion in the extremities *vital signs *hygiene and elimination *physical and psychological status and comfort (i.e. skin integrity, comfortable body temperature, the patient's dignity, mental status, and emotional well being) *readiness for release from restraints *patient's understanding of the reasons for restraint and requirements for release ...PATIENT/FAMILY EDUCATION: Restraint procedures should be performed in a manner that does not violate the patient's rights. ...For Non-Violent restraints, reassessment and documentation is required at least every 2 hours and for Violent/Self-Destructive restraints, it is required every 15 minutes. DOCUMENTATION: The medical record should document: *that the patient and/or family was informed of the organization's policy on the use of restraints; *any medical condition or any physical disability that would place the patient at greater risk during restraints/seclusion; *any history of sexual or physical abuse that would place the patient at grater psychological risk during restraint/seclusion. Documentation within the patient's record should indicate a clear progression in how techniques were implemented with the less intrusive restrictive intervention attempted or considered prior to the introduction of more restricted measure. When a restraint is initiated, the order must be documented immediately upon initiation. If the order for restraint is not initiated by the treating physician, the order must be followed by consultation with the patient's attending physician as soon as possible. ...Each episode of restraint/seclusion use is to be recorded in the medical record. Documentation will include: *date restraint applied *time restraint applied *type of Restraint (non-violent or violent/self destructive) *restraint device (soft, mitten, vest, geri-chair, etc.) *safe application verified *level of consciousness *safety/rights/dignity maintained verified *observed restraints appropriately intact *behavior during restraints *vital signs taken *free from injury associated with restraint *skin under/around restraint intact * range of motion done *circulation distal to restraint verified *offered nutrition/hydration *offered assistance with toileting/hygiene *offered comfort measures *the circumstances that led to restraint or seclusion use *consideration or failure of non-physical interventions including alternatives attempted and successful *the rationale for the type of physical intervention selected *notification of the patient's family/significant other, when appropriate *patient's response and any changes made as a result of the restraints *each telephone order received from a physician/LIP * debriefing of the patient with staff *any injuries that are sustained and treatment received from these injuries *any deaths. DISCONTINUING RESTRAINT DOCUMENTATION GUIDELINES *Criteria for restraint release met *Date restraint discontinued *Time restraint discontinued *Restraint debriefing when applicable for behavior (violent/self-destructive) MODIFICATION TO PATIENT'S PLAN OF CARE: The plan of care should clearly reflect a loop of assessment, intervention, evaluation and re-intervention. Restraint use must be in accordance with a written modification to the patient's plan of care..."

1. Observation during ED tour on 01/14/2015 at 1427 of exam room #17, revealed the room was located across from the nursing station. Observation revealed the room had a sliding glass door. Observation revealed a male patient (Patient #14) wearing green disposable scrubs and sitting on the end of the stretcher leaning over a bedside table. Observation revealed the stretcher's two side rails were up and in the locked position. Observation revealed the patient was alert, calm, and cooperative. Observation revealed the patient's right leg/ankle was chained to the stretcher's frame with a metal shackle/cuff (restraint). Observation revealed the patient did not exhibit any violent or self-destructive behaviors. Observation revealed the patient was in the exam room alone and without direct supervision of a LEO. At 1433, observation revealed Patient #14 stood up off the end of the stretcher and pivoted around to the side of the stretcher without difficulty or assistance. At 1434, observation revealed XYZ County Sheriff Deputy (CSD) #1 was sitting behind the nursing station in a cubical. Observation revealed the cubical was on the opposite side of the nursing station, away from exam room #17. Observation revealed CSD #1 stood up and exited the cubical and walked down the hallway on the opposite side of the nursing station, away from exam room #17 and exited the emergency department treatment area through a set of double doors. Observation revealed Patient #14 was alone in exam room #17 unsupervised by a LEO. At 1436, observation revealed CSD #1 returned to the cubical in the nursing station and sat down. Observations from 1427 to 1500 failed to observe any violent or self-destructive behaviors exhibited by Patient #14 while being restrained in exam room #17.

Open medical record review on 01/14/2015 revealed Patient #14, a [AGE] year old male presented to the hospital's ED on 01/13/2015 at 1820 accompanied by Law Enforcement under IVC petition. Review revealed the patient's chief complaint was IVC-Crisis Evaluation Referral. Review of triage nurse documentation at 1827 revealed "IVC, per caregiver pt (patient) with bizarre behavior, pt walking around showing gentials [sic], pt endorses auditory hallucinations, pt with rambling thoughts in triage, pt states he will only hurt someone if they try to hurt him." Review of triage assessment documentation revealed the patient was alert, oriented x 3 (person, place, time) and anxious. Review revealed the patient was evaluated by a physician at 1908. Review revealed a chief complaint of being agitated and exposing genitals. Review revealed the patient was assessed as no acute distress, awake and alert, slightly agitated, pressured speech, and directable. Review revealed the patient was "cooperative." Review of a "Findings and Custody Order Involuntary Commitment" revealed the order was signed on 01/13/2015 at 1541 by a Magistrate. Review revealed "The Court finds from the petition in the above matter that there are reasonable grounds to believe that the facts alleged in the petition are true and that the respondent (Patient #14) is probably: [X] 1. mentally ill and dangerous to self or others or mentally ill and in need of treatment in order to prevent further disability or deterioration that would predictably result in dangerousness. ..." Review of an "Examination and Recommendation to Determine Necessity for Involuntary Commitment" form dated 01/13/2015 at 2345 revealed "Description of Findings" with "...presenting for agitation, exposing himself inappropriately to others. On evaluation, pt is disorganized with pressured speech. Oriented to location but not situation. Is currently a danger to himself due to psychosis." Review of nursing documentation at 2235 revealed "Resting quietly in bed. No aggressive behaviors, no self-injurious behavior. ..." At 1215 (01/14/2015) "...Pt unshackled while bed was exchanged." At 1330 "Pt sitting at end of bed. No c/o voiced. No distress noted." At 1500 "Pt sitting on bed c (with) no distress noted." At 1845 "Pt transported to (hospital name)....ambulated to police care no distress noted." Review of "Suicide Precautions Flow sheet" documentation on 01/13/2015 from 1900 to 2300 and 01/14/2015 from 0715 to 1845 revealed the patient's behavior was documented by staff as calm or cooperative. Review revealed no documentation the patient was violent or aggressive. Review revealed on 01/14/2015 at 1430, 1445, and 1500 (corresponding timeframe to Surveyor's observation [1427-1500] of the patient cuffed/shackled to the stretcher) as being cooperative. Record review failed to reveal any available documentation Patient #14 exhibited violent or self-destructive behaviors necessitating the need for restraint use while hospitalized from [DATE] at 1820 through discharge on 01/14/2015 at 1845. Further record review failed to reveal documentation of ongoing monitoring and assessment of the patient at least every 15 minutes for violent/self-destructive restraint or every two hours for non-violent restraint (as appropriate to the type of restraint used) for one or more of the following: signs of injury associated with the restraints, nutrition/hydration, circulation and range of motion in the extremities, vital signs, hygiene and elimination, physical and psychological status and comfort (i.e. skin integrity, comfortable body temperature, the patient's dignity, mental status, and emotional well being), readiness for release from restraints, patient's understanding of the reasons for restraint and requirements for release, per hospital policy.

Interview on 01/13/2015 at 1107 during ED tour with Charge Nurse #1 revealed the only approved restraints used in the ED by nursing staff are "soft limb restraints." Interview revealed "only the Sheriff and Police Departments use handcuffs and shackles with IVC patients." Interview revealed the nurse is responsible for monitoring and assessing the patient when in handcuffs or shackles. Interview revealed the nursing staff is not responsible for applying the handcuffs or shackles.

Interview on 01/14/2015 at 1442 with CSD #1 revealed he was a Deputy Sheriff with the XYZ County Sheriff's Department. Interview revealed he was present in the ED for a "10-73" (mental subject). Interview revealed the patient (#14) in exam room #17 was under IVC. Interview revealed the patient was brought to the ED on 01/13/2015. Interview revealed he relieved the previous Deputy this morning (01/14/2015) at shift change. Interview revealed the previous Deputy placed the patient into "ankle shackles." Interview revealed the "officer makes the decision wither or not the patient needs to be handcuffed or shackled." Interview revealed Patient #14 was not going to jail and was not under arrest. Interview revealed he (CSD #1) was on standby until a mental health facility could be found for the patient. Interview revealed because the patient was in his custody, he was responsible for any of the patient's actions. Interview revealed when the patient complains the cuffs/shackles are too tight or hurting, he will use 2-3 fingers to check to see if the cuffs/shackles are too tight. Interview revealed there was no set schedule for periodically removing the cuffs/shackles or checking for tightness. Interview revealed the "patient lets me know if they are too tight." Interview revealed if the patient needed to go to the restroom, the cuffs/shackles are removed. Interview revealed he does not check pulses or skin for circulation. Interview revealed the nurse is responsible for taking care of the patient's medical needs. Interview revealed he does not document in the patients ED medical record.

Interview on 01/15/2015 at 1015 with the ED Medical Director revealed he spoke with a police officer with the ABC City Police Department while in the ED. Interview revealed the police officer stated the Chief of Police had determined that the IVC patients were in the custody of the police officer and that it was Departmental policy for all IVC patients to be placed into handcuffs or shackles while in the ED. Interview revealed "we can't control the police putting the patients in custody." Interview revealed "we can control the monitoring of the patients." The interview revealed " we have been trying to work through this for the past 9 months with Chief of Police."

Interview on 01/15/2015 at 1235 with the ED Nursing Director revealed patients brought into the ED under IVC or who are placed under IVC while in the ED were placed into "forensic" restraints (handcuffs or shackles) by the law enforcement officers. Interview revealed the ED staff did not view the placement of IVC patients in handcuffs or shackles as a restraint, because they were in the custody of law enforcement. Interview revealed there would not be any documentation of monitoring and assessment every 15 minutes (for violent self-destructive behavior) and/or 2 hours (for non-violent behavior), because the handcuffs and shackles were not considered a restrictive intervention by ED staff. Interview revealed the ED staff did not follow the hospital's Restraint of Patient policy for monitoring Patient #14 while he was restrained in the ED with metal cuffs/shackles placed by a law enforcement officer.

2. Observation during ED tour on 01/14/2015 at 1438 of exam room #5, revealed the room was located diagonally across from the nursing station. Observation revealed the room had a wood door. Observation revealed a female patient (Patient #16) wearing green disposable scrubs and laying on her left side on the stretcher, watching television. Observation revealed the stretcher's two side rails were up and in the locked position. Observation revealed the patient was alert, calm, and cooperative. Observation revealed the patient's left wrist was chained to the stretcher's frame with a metal cuff/shackle (restraint). Observation revealed the patient did not exhibit any violent or self-destructive behaviors. Observation revealed the patient was in the exam room alone and without direct supervision of a LEO. Observation revealed an ABC City Police Department officer was sitting behind the nursing station in a cubical, reading a magazine. Observations from 1438 to 1500 failed to observe any violent or self-destructive behaviors exhibited by Patient #16 while being restrained in exam room #5.

Open medical record review on 01/15/2015 for Patient #16 revealed an [AGE] year old female presented to the Hospital's ED on 01/13/2015 at 1726 for "potential drug overdose." Review revealed the patient was triaged by a RN at 1732 and was assessed by a ED Physician at 1734. Review revealed the patient was assessed at 1912 by a mobile crisis worker. Review revealed on 01/14/2015 at 0050, the patient was IVC for being mentally ill and dangerous to self and others. Review revealed at 0200 and 0400, the patient's behavior was documented as asleep with parent and LEO at bedside. Review revealed from 0600 to 01/15/2015 at 0515, the patient's behavior was documented as asleep, tearful, and resting quietly in bed, resting in bed with eyes closed and laying in bed with eyes closed. Review revealed at 0536, the patient requested the "shackle" (restraint) be loosened and the hospital staff informed the LEO. Review revealed at 0725, the patient behavior was documented as alert and oriented with right lower extremity "cuffed" (restraint) to bed frame. Review revealed at 0835, the patient was transferred to a Psychiatric hospital. Record review failed to reveal any available documentation Patient #16 exhibited violent or self-destructive behaviors necessitating the need for restraint use while hospitalized from [DATE] at 1726 through discharge on 01/15/2015 at 0835. Further record review failed to reveal documentation of ongoing monitoring and assessment of the patient at least every 15 minutes for violent/self-destructive restraint or every two hours for non-violent restraint (as appropriate to the type of restraint used).

Interview on 01/13/2015 at 1107 during ED tour with Charge Nurse #1 revealed the only approved restraints used in the ED by nursing staff are "soft limb restraints." Interview revealed "only the Sheriff and Police Departments use handcuffs and shackles with IVC patients." Interview revealed the nurse is responsible for monitoring and assessing the patient when in handcuffs or shackles. Interview revealed the nursing staff is not responsible for applying the handcuffs or shackles.

Interview with ABC Police Officer #1 on 01/14/2015 at 1435 revealed he was responsible for 3 patients under IVC in the ED at this time. The interview revealed he stations himself at an area in the corner. The interview revealed he can observe the patient in the seclusion room and the patient in room #5. The interview revealed Officer # 1 was not allowed to answer any further questions. The interview revealed a phone number to two Lieutenant at the City Police Department if further questions needed to be asked.

Interview on 01/15/2015 at 1015 with the ED Medical Director revealed he spoke with a police officer with the ABC City Police Department while in the ED. Interview revealed the police officer stated the Chief of Police had determined that the IVC patients were in the custody of the police officer and that it was Departmental policy for all IVC patients to be placed into handcuffs or shackles while in the ED. Interview revealed "we can't control the police putting the patients in custody." Interview revealed "we can control the monitoring of the patients." The interview revealed " we have been trying to work through this for the past 9 months with Chief of Police."

Interview on 01/15/2015 at 1235 with the ED Nursing Director revealed patients brought into the ED under IVC or who are placed under IVC while in the ED were placed into "forensic" restraints (handcuffs or shackles) by the law enforcement officers. Interview revealed the ED staff did not view the placement of IVC
VIOLATION: GOVERNING BODY Tag No: A0043
Based on hospital policy reviews, observations during tours, medical record reviews, grievance/complaint reviews, grievance log reviews, restraint list/log reviews, Law Enforcement Officer (LEO) interviews, staff and physician interviews the hospital's leadership failed to provide oversight and have systems in place to ensure the protection and promotion of Patients' Rights; an effective Quality Assurance Performance Improvement (QAPI) program; an organized Nursing Service; provide Emergency Services to meet the patients needs; and to maintain the facilities, supplies, and equipment at an acceptable level of safety and quality.

The findings include:

1. The hospital failed to protect and promote patients' rights in the Emergency Department (ED) for patients with psychiatric emergencies placed under under Involuntary Commitment (IVC).

~cross refer to 482.13 Patient Rights Condition - Tag A0115.

2. The hospital failed to maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement (QAPI) program for monitoring restraint in the ED.

~cross refer to 482.21 Quality Assessment and Performance Improvement (QAPI) Condition - Tag A0263.

3. The hospital nursing staff failed to ensure nursing supervision of care per the hospital policy and procedure when the staff failed to provide ongoing assessment and monitoring of the condition of patients during restraint or seclusion in the ED who were under IVC and for intensive care unit (ICU) patients not under IVC.

~cross refer to 482.23 Nursing Condition - Tag A0385.

4. The hospital failed to meet the emergency needs of behavioral health patients in accordance with the hospital's policy and procedures.

~cross refer to 482.55 Emergency Services Condition - Tag A1100.


5. The hospital's ED staff failed to maintain the facilities, supplies, and equipment in an manner to ensure an acceptable level of safety and quality for 1 of 1 ED toured.

~cross refer to 482.41 Physical Environment Standard - Tag A0724.
VIOLATION: PATIENT RIGHTS Tag No: A0115
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on hospital policy and procedure reviews, observations during tours, medical record reviews, complaint/grievance form reviews, grievance log reviews, Law Enforcement Officer (LEO) interviews, staff and physician interviews, the hospital failed to protect and promote patients' rights in the Emergency Department (ED) for patient's with psychiatric emergencies placed under under Involuntary Commitment (IVC).

The findings include:

1. The hospital's staff failed to provide a written notice of the hospital's decision to a grievance for 1 of 3 patient grievances reviewed (#1).

~cross refer to 482.13(a)(2)(iii) Patient Rights Standard - Tag A0123.

2. The hospital's ED staff failed to ensure exam rooms provided a safe environment for 4 of 4 patient's under IVC who were observed restrained in the ED (#14, #13, #16, #17).
~cross refer to 482.13(c)(2) Patient Rights Standard - Tag A0144.

3. The hospital's ED staff failed to ensure the least restrictive intervention to protect the patient or others from harm for 6 of 6 patients under IVC who were restrained in the ED (#14, #16, #13, #17, #12, #9).

~cross refer to 482.13(e)(3) Patient Rights Standard - Tag A0165.

4. The hospital's nursing staff failed to obtain a physician's order after placing a patient in restraints in 1 of 1 Intencsive Care Unit (ICU) patients (#2).

~cross refer to 482.13(e)(5) Patient Rights Standard - Tag A0168.

5. The hospital's ED staff failed to ensure a physician's restraint order was time limited for no longer than four (4) hours for 1 of 1 adult patient (#9) [AGE] years or older and for no longer than two (2) hours for 1 of 1 child and adolescent patient 9 to 17 years of age (#12) that was restrained or secluded for the management of violent or self-destructive behaviors.

~cross refer to 482.13(e)(8) Patient Rights Standard - Tag A0171.

6. The hospital's nursing staff failed to provide ongoing assessment and monitoring of the condition of a patient during restraint or seclusion for 6 of 6 ED patients (#14, #13, #16, #17, #12, #9) under IVC and 1 of 1 ICU patients not under IVC (#2).

~cross refer to 482.13(e)(10) Patient Rights Standard - Tag A0175.

7. The hospital's ED staff failed to ensure a 1-hour face-to-face evaluation was performed by a qualified physician or other licensed independent practitioner (LIP) or trained Registered Nurse (RN) after the initiation of restraint for 2 of 2 patients restrained in the ED for management of violent or self-destructive behaviors (#12, #9).

~cross refer to 482.13(e)(12) Patient Rights Standard - Tag A0178.

8. The hospital's ED staff failed to ensure the physician or other licensed independent practitioner (LIP) or trained RN conducting the face-to-face evaluation within 1 hour after the initiation of restraint evaluated the patient's immediate situation; the patient's reaction to the intervention; the patient's medical and behavioral condition; and the need to continue or terminate the restraint for 2 of 2 patients (#12, #9) restrained for the management of violent or self-destructive behaviors.

~cross refer to 482.13(e)(12) Patient Rights Standard - Tag A0179.
VIOLATION: PATIENT RIGHTS: NOTICE OF GRIEVANCE DECISION Tag No: A0123
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on hospital policy and procedure review, medical record reviews, complaint/grievance form reviews, grievance log review, and staff interviews the hospital's staff failed to provide a written notice of the hospital's decision to a grievance for 1 of 3 patient grievances reviewed (#1).

The findings include:

Review of current hospital policy, "Complaint and Grievance Resolution for Patients, ORG-11" with a revision date of 04/2012 revealed, "POLICY: [hospital name] maintains a process for addressing a patient's concerns regarding care of services rendered by the hospital in a timely, reasonable and consistent manner. ...PURPOSE: To provide a timely, courteous and personalized framework for problem resolution, service recovery and information sharing between [hospital name] and its patients, their family, significant others, employees and the medical staff. ...DEFINITIONS: ...Patient Complaint: ... Patient Grievance: ...Resolved: ...PROCEDURE: ...Complaint Procedure: ...Grievance Procedure: ...6. The Grievance Committee will review the grievance for appropriate follow-up and any needed action to resolve the grievance and will provide a written response to the patient and/or their representative within 7 days... 8. In extreme circumstance, if the grievance cannot be resolved in the seven (7) days required, the patient or the patient's representative must be informed that the hospital is still working to resolve the grievance and the that the hospital will follow-up with a written response within 30 days of receipt of the grievance. ..."

Closed medical record review on 01/13/2015 revealed on 08/22/2013, Patient #1, a [AGE]-year-old presented to the hospital ED (Emergency Department), while in the custody of [city] Police Department, as an IVC (Involuntary Commitment) due to mental illness and dangerous to self or others. Review revealed at 1645, the patient was evaluated by the mid-level provider. Review revealed at 2000, the patient received a mental health evaluation. Review revealed 08/23/2013 at 0400, an ED staff member was called to the patient room by LEO (Law Enforcement Officer) because the patient had [urinated] on the floor. Review revealed the patient "was screaming for 30 minutes," but no one responded when the patient was screaming. Review revealed on 08/23/2014 at 1310, the patient was accepted to a Psychiatric hospital for treatment. Review revealed at 1444, the patient was transported to the accepting hospital by the [county name] Sheriff Department.

Grievance Log review on 01/13/2015 revealed on 10/14/2014, Patient #1's grievance was logged. Review of the grievance details revealed the event occurred in the ED. Review revealed Patient #1 was "chained" to the bed and had to "holler for hours for someone to come" because the patient had to urinate. Review revealed Patient #1 urinated on the floor because no one would help the patient to the bathroom. Review revealed no documentation the hospital staff sent Patient #1 a written notice of the hospital determination to the grievance.

Interview on 01/15/2015 at 0900 with Director of Quality revealed Patient #1 was transferred to a Psychiatric hospital; therefore, no written notice of the hospital determination to the grievance was sent to the patient.

Complaint/Grievance Form review on 01/14/2015 revealed on 07/21/2014, Patient #1 filed a grievance related to being "chained to the bed" and "screamed and hollered for hours" because the patient had to go to the bathroom and no one would help the patient. Review revealed as a result, the patient urinated on the floor. Review revealed the event occurred in the ED. Review revealed no documentation the hospital staff sent Patient #1 a written notice of the hospital determination to the grievance.

Interview on 01/15/2015 at 0900 with Director of Quality revealed Patient #1 was transferred to a Psychiatric hospital; therefore, no written notice of the hospital determination the grievance was sent to the patient.
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based upon policy and procedure reviews, observations during tours, medical record reviews, Law Enforcement Officer (LEO) interviews, staff and physician interviews, the hospital's Emergency Department (ED) staff failed to ensure exam rooms provided a safe environment for 4 of 4 patient's under involuntary commitment who were observed restrained in the ED. (#14, #13, #16, #17)

The findings include:

Review of current hospital policy "Restraint of Patients, PC 17", revised 12/2014, revealed "PURPOSE: The use of restraints is a therapeutic intervention implemented to prevent the patient from injuring himself/herself or from injuring others. ...POLICY: It is the policy of (Hospital name) Medical Center to: ...2. Protect the patient and preserve the patient's rights, dignity and well being during restraint use by: ...b. maintaining a clean and safe environment..."

Interview on 01/14/2015 at 1420 during tour of the ED (1420-1500) with the Charge Nurse #2 revealed the ED had three (3) patients currently under involuntary commitment (IVC) in exam rooms #1, #5, #17 and one (1) patient pending IVC in exam room #7.

1. Observation during ED tour on 01/14/2015 at 1427 of exam room #17, revealed the room was located across from the nursing station. Observation revealed the room had a sliding glass door. Observation revealed inside the room was: a stretcher on wheels; a chair in the corner; a bed side table on wheels; removable wall mounted Oxygen, Medical Air, and Suction regulators; a disposable wall mounted suction canister and tubing; a wall mounted otoscope and ophthalmoscope with cords (each approximately 2-4 feet long); a wall mounted cardiac monitor with cardiac leads, blood pressure cuff, and pulse oximetry cords (each approximately 4-6 feet long) dangling from the monitor; and a wall mounted computer charting station. Further observation revealed a male patient (Patient #14) wearing green disposable scrubs and sitting on the end of the stretcher leaning over a bedside table. Observation revealed the stretcher's two side rails were up and in the locked position. Observation revealed a hand held call bell device (attached to the wall with an approximately 4-6 foot long cord) draped across the head of the stretcher onto the mattress within arms reach of the patient. Observation revealed the patient was alert, calm, and cooperative. Observation revealed the patient's right leg/ankle was chained to the stretcher's frame with a metal shackle/cuff (restraint). Observation revealed the patient did not exhibit any violent or self-destructive behaviors. Observation revealed the patient was in the exam room alone and without direct supervision of a LEO or nursing staff. At 1433, observation revealed Patient #14 stood up off the end of the stretcher and pivoted around to the side of the stretcher without difficulty or assistance. Observation revealed the patient was within arms reach of the wall mounted medical equipment.

Open medical record review on 01/14/2015 revealed Patient #14, a [AGE] year old male presented to the hospital's ED on 01/13/2015 at 1820 accompanied by Law Enforcement under IVC petition. Review revealed the patient's chief complaint was IVC-Crisis Evaluation Referral. Review of triage nurse documentation at 1827 revealed "IVC, per caregiver pt (patient) with bizarre behavior, pt walking around showing gentials [sic], pt endorses auditory hallucinations, pt with rambling thoughts in triage, pt states he will only hurt someone if they try to hurt him." Review of triage assessment documentation revealed the patient was alert, oriented x 3 (person, place, time) and anxious. Review revealed the patient was evaluated by a physician at 1908. Review revealed a chief complaint of being agitated and exposing genitals. Review revealed the patient was assessed as no acute distress, awake and alert, slightly agitated, pressured speech, and directable. Review revealed the patient was "cooperative." Review of a "Findings and Custody Order Involuntary Commitment" revealed the order was signed on 01/13/2015 at 1541 by a Magistrate. Review revealed "The Court finds from the petition in the above matter that there are reasonable grounds to believe that the facts alleged in the petition are true and that the respondent (Patient #14) is probably: [X] 1. mentally ill and dangerous to self or others or mentally ill and in need of treatment in order to prevent further disability or deterioration that would predictably result in dangerousness. ..." Review of an "Examination and Recommendation to Determine Necessity for Involuntary Commitment" form dated 01/13/2015 at 2345 revealed "Description of Findings" with "...presenting for agitation, exposing himself inappropriately to others. On evaluation, pt is disorganized with pressured speech. Oriented to location but not situation. Is currently a danger to himself due to psychosis."

Interview on 01/15/2015 at 1235 with the ED Nursing Director revealed "seclusion (exam room #7) is the only room we can remove everything to make it safe." Interview revealed with IVC patient's the ED staff does not necessarily remove all equipment from the room. Interview revealed ED staff are looking at processes to make a consistent decision point as to making a safe environment. Interview revealed "In reality it is a general ED and not a psychiatric unit." Interview revealed all the equipment in the exam rooms can be removed except for wall mounted computers and the call bell which has to be plugged into the wall. Interview revealed the ED "needs to improve the process to standardize versus being an individual decision" for making rooms safe.

2. Observation during ED tour on 01/14/2015 at 1430 of exam room #1, revealed an ante room was located diagonally across from the nursing station. Observation revealed the room was an isolation room. Observation revealed to view a patient required walking into the ante room, turning right and proceeding approximately 4 feet to enter the isolation room proper. Observation revealed a male patient (Patient #13) wearing green disposable scrubs and laying supine on the stretcher with both hands across his abdomen. Observation revealed the stretcher's two side rails were up. Observation revealed the patient was alert, calm, and cooperative. Observation revealed the patient's right ankle was chained to the stretcher's frame with a metal cuff/shackle (restraint). Observation revealed the patient did not exhibit any violent or self-destructive behaviors. Observation revealed the patient was in the isolation room alone and without direct supervision of a LEO. Observation revealed an ABC City Police Department officer was sitting behind the nursing station in a cubical and due to location he could not observe the patient. Observation revealed from the LEO's location the ante room could be observed only. Observations from 1430 to 1500 failed to observe any violent or self-destructive behaviors exhibited by Patient #16 while being restrained in exam room #7.

Open medical record review on 01/14/2015 for Patient #13 revealed a [AGE] year old male (MDS) dated [DATE] at 0125 with thoughts of suicide and for substance abuse detoxification. Review revealed at 0127, the patient was triaged by a RN and at 0234, the patient was assessed by a ED Physician. Review revealed at 0840, the patient was assessed by a mobile crisis worker and was admitted for suicidal thoughts. Review revealed at 1600, the patient was IVC'd due to mentally ill and dangerous to self and others. Further review revealed when the patient was IVC'd, a LEO placed the patient in leg shackles (restraint). Review revealed at 1800 and 2000, the patient's behavior was documented as calm and resting with eyes closed with the right ankle in shackled. Review revealed on 01/14/2015 at 0000, 0200, 0430, 0600, 0735 and 0935, the patient behavior was documented as asleep and resting quietly with the right ankle shackled. Review revealed at 1645, the patient was transferred to a psychiatric hospital for further treatment. Review revealed no documentation the patient demonstrated violent or self-destructive behaviors. Record review failed to reveal any available documentation Patient #13 exhibited violent or self-destructive behaviors necessitating the need for restraint use while hospitalized from [DATE] at 0125 through discharge on 01/14/2015 at 1645.

Interview on 01/15/2015 at 1235 with the ED Nursing Director revealed "seclusion (exam room #7) is the only room we can remove everything to make it safe." Interview revealed with IVC patient's the ED staff does not necessarily remove all equipment from the room. Interview revealed ED staff are looking at processes to make a consistent decision point as to making a safe environment. Interview revealed "In reality it is a general ED and not a psychiatric unit." Interview revealed all the equipment in the exam rooms can be removed except for wall mounted computers and the call bell which has to be plugged into the wall. Interview revealed the ED "needs to improve the process to standardize versus being an individual decision" for making rooms safe.

3. Observation during ED tour on 01/14/2015 at 1438 of exam room #5, revealed the room was located diagonally across from the nursing station. Observation revealed the room had a wood door. Observation revealed inside the room was: a stretcher on wheels; a chair in the corner; a bed side table on wheels; removable wall mounted Oxygen, Medical Air, and Suction regulators; a disposable wall mounted suction canister and tubing; a wall mounted otoscope and ophthalmoscope with cords (each approximately 2-4 feet long); a wall mounted cardiac monitor with cardiac leads, blood pressure cuff, and pulse oximetry cords (each approximately 4-6 feet long) dangling from the monitor; and a wall mounted computer charting station. Further observation revealed a female patient (Patient #16) wearing green disposable scrubs and laying on her left side on the stretcher, watching television. Observation revealed the stretcher's two side rails were up and in the locked position. Observation revealed a hand held call bell device (attached to the wall with an approximately 4-6 foot long cord) draped across the left side rail of the stretcher within arms reach of the patient. Observation revealed the patient was alert, calm, and cooperative. Observation revealed the patient's left wrist was chained to the stretcher's frame with a metal cuff/shackle (restraint). Observation revealed the patient did not exhibit any violent or self-destructive behaviors. Observation revealed the patient was in the exam room alone and without direct supervision of a LEO or nursing staff.

Open medical record review on 01/15/2015 for Patient #16 revealed an [AGE] year old female presented to the Hospital's ED on 01/13/2015 at 1726 for "potential drug overdose." Review revealed the patient was triaged by a RN at 1732 and was assessed by a ED Physician at 1734. Review revealed the patient was assessed at 1912 by a mobile crisis worker. Review revealed on 01/14/2015 at 0050, the patient was placed under IVC for being mentally ill and dangerous to self and others. Review revealed at on 01/15/2015 at 0835, the patient was transferred to a Psychiatric hospital.

Interview on 01/15/2015 at 1235 with the ED Nursing Director revealed "seclusion (exam room #7) is the only room we can remove everything to make it safe." Interview revealed with IVC patient's the ED staff does not necessarily remove all equipment from the room. Interview revealed ED staff are looking at processes to make a consistent decision point as to making a safe environment. Interview revealed "In reality it is a general ED and not a psychiatric unit." Interview revealed all the equipment in the exam rooms can be removed except for wall mounted computers and the call bell which has to be plugged into the wall. Interview revealed the ED "needs to improve the process to standardize versus being an individual decision" for making rooms safe.




4. Observation during ED tour on 01/14/2015 at 1430 of the seclusion room #7 revealed a room with a solid wood door and window with blinds and the blinds were outside covering the window. Observation revealed on the left side of the room at the head of the stretcher a metal plate with two sharp pointed corners partially attached to the wall. Observation revealed the metal plate could be easily pulled further off of the wall. When exiting the room a male patient (Patient #17) was observed standing calmly beside with door EMS personnel at his side. Observation revealed the patient was escorted into the seclusion room along with the Mental Health Nurse (MHRN). Approximately 10 minutes later 2 City LEOs were observed entering the seclusion room and the MHRN standing out side of the room. The door and the blinds were closed. Interview with the MHRN during the observation revealed City LEO were in the room searching the patient, putting the patient in scrubs and cuffing (restraints) the patient. The interview revealed the LEO cuffed the patient because the patient was IVC. The interview revealed that even if the patient is calm and cooperative the patient is always cuffed. The interview revealed the MHRN had training on the Hospital policy and procedure for restraining patients in October, 2014. The interview revealed she was also aware of the revision of the restraint and seclusion policy completed in December, 2014. Patient #17 was observed during the interview with both wrist cuffed with metal cuffs. Observation revealed the patient did not exhibit any violent or self-destructive behaviors.

Interview on 01/15/2015 at 1235 with the ED Nursing Director revealed "seclusion (exam room #7) is the only room we can remove everything to make it safe." Interview revealed with IVC patient's the ED staff does not necessarily remove all equipment from the room. Interview revealed ED staff are looking at processes to make a consistent decision point as to making a safe environment. Interview revealed "In reality it is a general ED and not a psychiatric unit." Interview revealed all the equipment in the exam rooms can be removed except for wall mounted computers and the call bell which has to be plugged into the wall. Interview revealed the ED "needs to improve the process to standardize versus being an individual decision" for making rooms safe.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0165
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based upon policy and procedure reviews, observations during tours, medical record reviews, Law Enforcement Officer (LEO) interviews, staff and physician interviews, the hospital's Emergency Department (ED) staff failed to ensure the least restrictive intervention to protect the patient or others from harm for 6 of 6 patients under involuntary commitment who were restrained in the ED. (#14, #16, #13, #17, #12, #9)

The findings include:

Review of current hospital policy "Restraint of Patients, PC 17", revised 12/2014, revealed "PURPOSE: The use of restraints is a therapeutic intervention implemented to prevent the patient from injuring himself/herself or from injuring others. The decision to use a restraint is driven by a comprehensive individual assessment. This document is used to provide consistent guidelines for the safe use of chemical and physical restraints and seclusion, if alternatives, as determined by an interdisciplinary team, have proven to be clinically ineffective to provide a safe environment for the patient. ...DEFINITIONS: Restraint - is the direct application of physical force to a patient, with or without the patient's permission, to restrict his or her freedom of movement. The physical force may be human, mechanical devices, or a combination thereof. Physical Restraints - any manual method or physical/mechanical device, material or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely. ...Restraint to Promote Medical Recovery (non-violent): refers to the use of restraints in those patients who require various medically essential therapies while hospitalized and who demonstrate a state of confusion or altered cognition that puts those therapies at risk OR those patients who require management of non-psychiatric behaviors that put them at risk for injury. Restraints for Violent or Self-Destructive Behavior: refers to the use of restraints in those patients who require management of violent or self-destructive behavior towards themselves or others (including caregivers or other patients) or, who require physical restraint to manage suicidal or homicidal behaviors in ANY setting. ...Restrictive Devices Applied by Law Enforcement Officials - handcuffs and other restrictive devices applied by law enforcement officials for custody, detention, and public safety reasons and is not involved in the provision of health care; no considered restraints. ...Seclusion - seclusion is the involuntary confinement of a patient alone in a room or area from which the patient is physically prevented from leaving. Seclusion may only be used for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others. The following interventions are not considered seclusion: 1. a patient physically restrained alone in an unlocked room. ...POLICY: It is the policy of (Hospital name) Medical Center to: 1. Prevent, reduce and eliminate the use of restraints by: a. preventing emergencies that have the potential to lead to the use of restraints, b. limiting the use of restraints to emergencies where there is a risk of the patient harming himself/herself or others. c. using the least restrictive method. ...CLINICAL JUSTIFICATION FOR USE OF RESTRAINT AND/OR SECLUSION: ...Unless there is an immediate and overriding concern for safety, the restraint procedure is utilized only after all alternatives, less restrictive treatment interventions have been tried without success. Prior to implementation of any restraint, care team members will confer to determine that appropriate alternative measures have been attempted. Using the decision flowcharts for patient behaviors and alternatives for use of restraint, clinical assessment and utilization of restraint should be based on patient's behavior that may place the patient or others at risk for harm. Situations in which restraints are clinically justified include: *Threatens placement and/or patiency of necessary therapeutic lines/tubs, interfering with necessary medical treatment, and appropriate alternative measures have been attempted. ...*Unable to follow directions to avoid self-injury, and appropriate protective, alternative measures have been attempted. ...LEAST RESTRICTIVE RESTRAINT/SAFE APPLICATION: Assessment and reassessment processes should include the appropriateness of the choice of restraint and/or seclusion. ...ALTERNATIVE THERAPY: Prior to physically restraining a patient, restraint-free interventions such as (but not limited to) the following are attempted: *Provide safe environment, i.e., bed in low position, clutter free environment *Diversonal Activity *Assess for continued need for medical device ...*Telephone limit setting/redirection *Enhanced observation *Address comfort needs... *Ask/allow family to stay with patient - family interaction *Relaxation aids... *Limiting visitors *Bed alarms *Provide exercise/ambulation if condition warrants *Eliminate unnecessary medications *Mittens... *Move patient to a room closer to nurse's station *Provide increased physical contact... *Camouflage lines/tubes *Personal space for placing belongings or pictures within ease reach *Listening and exploring feelings ...Pain management *Music/TV *Reassurance *Sitter *Change of Environment ...MONITORING, ASSESSING, AND CARE OF THE PATIENT IN RESTRAINTS: When restraints are used there is an increased need for patient monitoring and assessment to assure patient safety, that the less restrictive methods are used when possible, and that restraint is discontinued as soon as possible. ...DOCUMENTATION: The medical record should document: ...Documentation within the patient's record should indicate a clear progression in how techniques were implemented with the less intrusive restrictive intervention attempted or considered prior to the introduction of more restricted measure. ..."

Interview on 01/14/2015 at 1420 during tour of the ED (1420-1500) with the Charge Nurse #2 revealed the ED had three (3) patients currently under involuntary commitment (IVC) in exam rooms #1, #5, #17 and one (1) patient pending IVC in exam room #7.

1. Observation during ED tour on 01/14/2015 at 1427 of exam room #17, revealed the room was located across from the nursing station. Observation revealed the room had a sliding glass door. Observation revealed a male patient (Patient #14) wearing green disposable scrubs and sitting on the end of the stretcher leaning over a bedside table. Observation revealed the stretcher's two side rails were up and in the locked position. Observation revealed the patient was alert, calm, and cooperative. Observation revealed the patient's right leg/ankle was chained to the stretcher's frame with a metal shackle/cuff (restraint). Observation revealed the patient did not exhibit any violent or self-destructive behaviors. Observation revealed the patient was in the exam room alone and without direct supervision of a LEO. At 1433, observation revealed Patient #14 stood up off the end of the stretcher and pivoted around to the side of the stretcher without difficulty or assistance. At 1434, observation revealed XYZ County Sheriff Deputy (CSD) #1 was sitting behind the nursing station in a cubical. Observation revealed the cubical was on the opposite side of the nursing station, away from exam room #17. Observation revealed CSD #1 stood up and exited the cubical and walked down the hallway on the opposite side of the nursing station, away from exam room #17 and exited the emergency department treatment area through a set of double doors. Observation revealed Patient #14 was alone in exam room #17 unsupervised by a LEO. At 1436, observation revealed CSD #1 returned to the cubical in the nursing station and sat down. Observations from 1427 to 1500 failed to observe any violent or self-destructive behaviors exhibited by Patient #14 while being restrained in exam room #17.

Open medical record review on 01/14/2015 revealed Patient #14, a [AGE] year old male presented to the hospital's ED on 01/13/2015 at 1820 accompanied by Law Enforcement under IVC petition. Review revealed the patient's chief complaint was IVC-Crisis Evaluation Referral. Review of triage nurse documentation at 1827 revealed "IVC, per caregiver pt (patient) with bizarre behavior, pt walking around showing gentials [sic], pt endorses auditory hallucinations, pt with rambling thoughts in triage, pt states he will only hurt someone if they try to hurt him." Review of triage assessment documentation revealed the patient was alert, oriented x 3 (person, place, time) and anxious. Review revealed the patient was evaluated by a physician at 1908. Review revealed a chief complaint of being agitated and exposing genitals. Review revealed the patient was assessed as no acute distress, awake and alert, slightly agitated, pressured speech, and directable. Review revealed the patient was "cooperative." Review of a "Findings and Custody Order Involuntary Commitment" revealed the order was signed on 01/13/2015 at 1541 by a Magistrate. Review revealed "The Court finds from the petition in the above matter that there are reasonable grounds to believe that the facts alleged in the petition are true and that the respondent (Patient #14) is probably: [X] 1. mentally ill and dangerous to self or others or mentally ill and in need of treatment in order to prevent further disability or deterioration that would predictably result in dangerousness. ..." Review of an "Examination and Recommendation to Determine Necessity for Involuntary Commitment" form dated 01/13/2015 at 2345 revealed "Description of Findings" with "...presenting for agitation, exposing himself inappropriately to others. On evaluation, pt is disorganized with pressured speech. Oriented to location but not situation. Is currently a danger to himself due to psychosis." Review of nursing documentation at 2235 revealed "Resting quietly in bed. No aggressive behaviors, no self-injurious behavior. ..." At 1215 (01/14/2015) "...Pt unshackled while bed was exchanged." At 1330 "Pt sitting at end of bed. No c/o voiced. No distress noted." At 1500 "Pt sitting on bed c (with) no distress noted." At 1845 "Pt transported to (hospital name)....ambulated to police care no distress noted." Review of "Suicide Precautions Flow sheet" documentation on 01/13/2015 from 1900 to 2300 and 01/14/2015 from 0715 to 1845 revealed the patient's behavior was documented by staff as calm or cooperative. Review revealed no documentation the patient was violent or aggressive. Review revealed on 01/14/2015 at 1430, 1445, and 1500 (corresponding timeframe to Surveyor's observation [1427-1500] of the patient cuffed/shackled to the stretcher) as being cooperative. Record review failed to reveal any available documentation Patient #14 exhibited violent or self-destructive behaviors necessitating the need for restraint use while hospitalized from [DATE] at 1820 through discharge on 01/14/2015 at 1845. Record review failed to reveal documentation prior to physically restraining Patient #14 of all restraint-free alternatives and less restrictive interventions such as (but not limited to) the following were attempted: provide safe environment, diversional activity, assessment for continued need for any medical devices, telephone limit setting/redirection, enhanced observation, addressing comfort needs, asking/allowing family to stay with patient - family interaction, relaxation aids, limiting visitors, bed alarms, providing exercise/ambulation if condition warrants, eliminating unnecessary medications, mittens, moving the patient to a room closer to nurse's station, providing increased physical contact, camouflaging lines/tubes, personal space for placing belongings or pictures within ease reach, listening and exploring feelings, pain management, music/TV, reassurance, sitter, change of environment, that were tried without success; nor documentation within the patient's record indicating a clear progression in how techniques were implemented with the less intrusive restrictive intervention attempted or considered prior to the introduction of more restricted measure per hospital policy.

Interview on 01/13/2015 at 1107 during ED tour with Charge Nurse #1 revealed the only approved restraints used in the ED by nursing staff are "soft limb restraints." Interview revealed "only the Sheriff and Police Departments use handcuffs and shackles with IVC patients." Interview revealed the nurse is responsible for monitoring and assessing the patient when in handcuffs or shackles. Interview revealed the nursing staff is not responsible for applying the handcuffs or shackles.

Interview on 01/14/2015 at 1442 with CSD #1 revealed he was a Deputy Sheriff with the XYZ County Sheriff's Department. Interview revealed he was present in the ED for a "10-73" (mental subject). Interview revealed the patient (#14) in exam room #17 was under IVC. Interview revealed the patient was brought to the ED on 01/13/2015. Interview revealed he relieved the previous Deputy this morning (01/14/2015) at shift change. Interview revealed the previous Deputy placed the patient into "ankle shackles." Interview revealed the "officer makes the decision wither or not the patient needs to be handcuffed or shackled." Interview revealed Patient #14 was not going to jail and was not under arrest. Interview revealed he (CSD #1) was on standby until a mental health facility could be found for the patient. Interview revealed because the patient was in his custody, he was responsible for any of the patient's actions. Interview revealed when the patient complains the cuffs/shackles are too tight or hurting, he will use 2-3 fingers to check to see if the cuffs/shackles are too tight. Interview revealed there was no set schedule for periodically removing the cuffs/shackles or checking for tightness. Interview revealed the "patient lets me know if they are too tight." Interview revealed if the patient needed to go to the restroom, the cuffs/shackles are removed. Interview revealed he does not check pulses or skin for circulation. Interview revealed the nurse is responsible for taking care of the patient's medical needs. Interview revealed he does not document in the patients ED medical record.

Interview on 01/15/2015 at 1015 with the ED Medical Director revealed he spoke with a police officer with the ABC City Police Department while in the ED. Interview revealed the police officer stated the Chief of Police had determined that the IVC patients were in the custody of the police officer and that it was Departmental policy for all IVC patients to be placed into handcuffs or shackles while in the ED. Interview revealed "we can't control the police putting the patients in custody." Interview revealed "we can control the monitoring of the patients." The interview revealed " we have been trying to work through this for the past 9 months with Chief of Police."

Interview on 01/15/2015 at 1235 with the ED Nursing Director revealed patients brought into the ED under IVC or who are placed under IVC while in the ED were placed into "forensic" restraints (handcuffs or shackles) by the law enforcement officers. Interview revealed the ED staff did not view the placement of IVC patients in handcuffs or shackles as a restraint, because they were in the custody of law enforcement. Interview revealed there would not be any documentation of monitoring and assessment every 15 minutes (for violent self-destructive behavior) and/or 2 hours (for non-violent behavior), because the handcuffs and shackles were not considered a restrictive intervention by ED staff. Interview revealed the ED staff did not follow the hospital's Restraint of Patient policy for monitoring Patient #14 while he was restrained in the ED with metal cuffs/shackles placed by a law enforcement officer.




2. Observation during ED tour on 01/14/2015 at 1438 of exam room #5, revealed the room was located diagonally across from the nursing station. Observation revealed the room had a wood door. Observation revealed a female patient (Patient #16) wearing green disposable scrubs and laying on her left side on the stretcher, watching television. Observation revealed the stretcher's two side rails were up and in the locked position. Observation revealed the patient was alert, calm, and cooperative. Observation revealed the patient's left wrist was chained to the stretcher's frame with a metal cuff/shackle (restraint). Observation revealed the patient did not exhibit any violent or self-destructive behaviors. Observation revealed the patient was in the exam room alone and without direct supervision of a LEO. Observation revealed an ABC City Police Department officer was sitting behind the nursing station in a cubical, reading a magazine. Observations from 1438 to 1500 failed to observe any violent or self-destructive behaviors exhibited by Patient #16 while being restrained in exam room #5.

Open medical record review on 01/15/2015 for Patient #16 revealed an [AGE] year old female presented to the Hospital's ED on 01/13/2015 at 1726 for "potential drug overdose." Review revealed the patient was triaged by a RN at 1732 and was assessed by a ED Physician at 1734. Review revealed the patient was assessed at 1912 by a mobile crisis worker. Review revealed on 01/14/2015 at 0050, the patient was IVC for being mentally ill and dangerous to self and others. Review revealed at 0200 and 0400, the patient's behavior was documented as asleep with parent and LEO at bedside. Review revealed from 0600 to 01/15/2015 at 0515, the patient's behavior was documented as asleep, tearful, and resting quietly in bed, resting in bed with eyes closed and laying in bed with eyes closed. Review revealed at 0536, the patient requested the "shackle" (restraint) be loosened and the hospital staff informed the LEO. Review revealed at 0725, the patient behavior was documented as alert and oriented with right lower extremity "cuffed" (restraint) to bed frame. Review revealed at 0835, the patient was transferred to a psychiatric hospital. Record review failed to reveal any available documentation Patient #16 exhibited violent or self-destructive behaviors necessitating the need for restraint use while hospitalized from [DATE] at 1726 through discharge on 01/15/2015 at 0835. Record review failed to reveal documentation prior to physically restraining Patient #16 of all restraint-free alternatives and less restrictive interventions such as (but not limited to) the following were attempted: provide safe environment, diversional activity, assessment for continued need for any medical devices, telephone limit setting/redirection, enhanced observation, addressing comfort needs, asking/allowing family to stay with patient - family interaction, relaxation aids, limiting visitors, bed alarms, providing exercise/ambulation if condition warrants, eliminating unnecessary medications, mittens, moving the patient to a room closer to nurse's station, providing increased physical contact, camouflaging lines/tubes, personal space for placing belongings or pictures within ease reach, listening and exploring feelings, pain management, music/TV, reassurance, sitter, change of environment, that were tried without success; nor documentation within the patient's record indicating a clear progression in how techniques were implemented with the less intrusive restrictive intervention attempted or considered prior to the introduction of more restricted measure per hospital policy.

Interview on 01/13/2015 at 1107 during ED tour with Charge Nurse #1 revealed the only approved restraints used in the ED by nursing staff are "soft limb restraints." Interview revealed "only the Sheriff and Police Departments use handcuffs and shackles with IVC patients." Interview revealed the nurse is responsible for monitoring and assessing the patient when in handcuffs or shackles. Interview revealed the nursing staff is not responsible for applying the handcuffs or shackles.

Interview with ABC Police Officer #1 on 01/14/2015 at 1435 revealed he was responsible for 3 patients under IVC in the ED at this time. The interview revealed he stations himself at an area in the corner. The interview revealed he can observe the patient in the seclusion room and the patient in room #5. The interview revealed Officer #1 was not allowed to answer any further questions. The interview revealed a phone number to two Lieutenant at the City Police Department if further questions needed to be asked.

Interview on 01/15/2015 at 1015 with the ED Medical Director revealed he spoke with a police officer with the ABC City Police Department while in the ED. Interview revealed the police officer stated the Chief of Police had determined that the IVC patients were in the custody of the police officer and that it was Departmental policy for all IVC patients to be placed into handcuffs or shackles while in the ED. Interview revealed "we can't control the police putting the patients in custody." Interview revealed "we can control the monitoring of the patients." The interview revealed " we have been trying to work through this for the past 9 months with Chief of Police."

Interview on 01/15/2015 at 1235 with the ED Nursing Director revealed patients brought into the ED under IVC or who are placed under IVC while in the ED were placed into "forensic" restraints (handcuffs or shackles) by the law enforcement officers. Interview revealed the ED staff did not view the placement of IVC patients in handcuffs or shackles as a restraint, because they were in the custody of law enforcement. Interview revealed there would not be any documentation of monitoring and assessment every 15 minutes (for violent self-destructive behavior) and/or 2 hours (for non-violent behavior), because the handcuffs and shackles were not considered a restrictive intervention by ED staff. Interview revealed the ED staff did not follow the hospital's Restraint of Patient policy for monitoring Patient #16 while he was restrained in the ED with metal cuffs/shackles placed by a law enforcement officer.

3. Observation during ED tour on 01/14/2015 at 1430 of exam room #1, revealed an ante room was located diagonally across from the nursing station. Observation revealed the room was an isolation room. Observation revealed to view a patient required walking into the ante room, turning right and proceeding approximately 4 feet to enter the isolation room proper. Observation revealed a male patient (Patient #13) wearing green disposable scrubs and laying supine on the stretcher with both hands across his abdomen. Observation revealed the stretcher's two side rails were up. Observation revealed the patient was alert, calm, and cooperative. Observation revealed the patient's right ankle was chained to the stretcher's frame with a metal cuff/shackle (restraint). Observation revealed the patient did not exhibit any violent or self-destructive behaviors. Observation revealed the patient was in the isolation room alone and without direct supervision of a LEO. Observation revealed an ABC City Police Department officer was sitting behind the nursing station in a cubical and due to location he could not observe the patient. Observation revealed from the LEO's location the ante room could be observed only. Observations from 1430 to 1500 failed to observe any violent or self-destructive behaviors exhibited by Patient #16 while being restrained in exam room #7.

Open medical record review on 01/14/2015 for Patient #13 revealed a [AGE] year old male presented to the hospital ED (Emergency Department) on 01/13/2015 at 0125 with thoughts of suicide and for substance abuse detoxification. Review revealed at 0127, the patient was triaged by a RN and at 0234, the patient was assessed by a ED Physician. Review revealed at 0840, the patient was assessed by a mobile crisis worker and was admitted for suicidal thoughts. Review revealed at 1600, the patient was IVC (Involuntary Commitment) due to mentally ill and dangerous to self and others. Further review revealed when the patient was IVC, LEO (Law Enforcement Officer) placed the patient in leg shackles. Review revealed at 1800 and 2000, the patient's behavior was documented as calm and resting with eyes closed with "lower extremity" (leg) shackled (restraint). Review revealed on 01/14/2015 at 0000, 0200, 0430, 0600, 0735 and 0935, the patient behavior was documented as asleep and resting quietly with the right ankle shackled. Review revealed at 1645, the patient was transferred to a Psychiatric hospital for treatment. Review revealed no documentation the patient demonstrated violent or self-destructive behaviors. Record review failed to reveal any available documentation Patient #13 exhibited violent or self-destructive behaviors necessitating the need for restraint use while hospitalized from [DATE] at 0125 through discharge on 01/14/2015 at 1645. Record review failed to reveal documentation prior to physically restraining Patient #13 of all restraint-free alternatives and less restrictive interventions such as (but not limited to) the following were attempted: provide safe environment, diversional activity, assessment for continued need for any medical devices, telephone limit setting/redirection, enhanced observation, addressing comfort needs, asking/allowing family to stay with patient - family interaction, relaxation aids, limiting visitors, bed alarms, providing exercise/ambulation if condition warrants, eliminating unnecessary medications, mittens, moving the patient to a room closer to nurse's station, providing increased physical contact, camouflaging lines/tubes, personal space for placing belongings or pictures within ease reach, listening and exploring feelings, pain management, music/TV, reassurance, sitter, change of environment, that were tried without success; nor documentation within the patient's record indicating a clear progression in how techniques were implemented with the less intrusive restrictive intervention attempted or considered prior to the introduction of more restricted measure per hospital policy.

Interview on 01/13/2015 at 1107 during ED tour with Charge Nurse #1 revealed the only approved restraints used in the ED by nursing staff are "soft limb restraints." Interview revealed "only the Sheriff and Police Departments use handcuffs and shackles with IVC patients." Interview revealed the nurse is responsible for monitoring and assessing the patient when in handcuffs or shackles. Interview revealed the nursing staff is not responsible for applying the handcuffs or shackles.

Interview with ABC Police Officer #1 on 01/14/2015 at 1435 revealed he was responsible for 3 patients under IVC in the ED at this time. The interview revealed he stations himself at an area in the corner. The interview revealed he can observe the patient in the seclusion room and the patient in room #5. The interview revealed Officer #1 was not allowed to answer any further questions. The interview revealed a phone number to two Lieutenant at the City Police Department if further questions needed to be asked.

Interview on 01/15/2015 at 1015 with the ED Medical Director revealed he spoke with a police officer with the ABC City Police Department while in the ED. Interview revealed the police officer stated the Chief of Police had determined that the IVC patients were in the custody of the police officer and that it was Departmental policy for all IVC patients to be placed into handcuffs or shackles while in the ED. Interview revealed "we can't control the police putting the patients in custody." Interview revealed "we can control the monitoring of the patients." The interview revealed " we have been trying to work through this for the past 9 months with Chief of Police."

Interview on 01/15/2015 at 1235 with the ED Nursing Director revealed patients brought into the ED under IVC or who are placed under IVC while in the ED were placed into "forensic" restraints (handcuffs or shackles) by the law enforcement officers. Interview revealed the ED staff did not view the placement of IVC patients in handcuffs or shackles as a restraint, because they were in the custody of law enforcement. Interview revealed there would not be any documentation of monitoring and assessment every 15 minutes (for violent self-destructive behavior) and/or 2 hours (for non-violent behavior), because the handcuffs and shackles were not considered a restrictive intervention by ED staff. Interview revealed the ED staff did not follow the hospital's Restraint of Patient policy for monitoring Patient #13 while he was restrained in the ED with metal cuffs/shackles placed by a law enforcement officer.




4. Observation during ED tour on 01/14/2015 at 1430 of the seclusion room #7 revealed a room with a solid wood door and window with blinds and the blinds were outside covering the window. Observation revealed on the left side of the room at the head of the stretcher a metal plate with two sharp pointed corners partially attached to the wall. Observation revealed the metal plate could be easily pulled further off of the wall. When exiting the room a male patient (Patient #17) was observed standing calmly beside with door EMS personnel at his side. Observation revealed the patient was escorted into the seclusion room along with the Mental Health Nurse (MHRN). Approximately 10 minutes 2 City LEOs were observed entering the seclusion room and the MHRN standing out side of the room. The door and the blinds were closed. Interview with the MHRN during the observation revealed City LEO were in the room searching the patient, putting the patient in scrubs and cuffing the patient. The interview revealed the LEO cuffed the patient because the patient was IVC. The interview revealed that even if the patient is calm and cooperative the patient is always cuffed. The interview revealed the MHRN had training on the Hospital policy and procedure for restraining patients in October, 2014. The interview revealed she was also aware of the revision of the restraint and seclusion policy completed in December, 2014. Patient #17 was observed during the interview with both wrist cuffed with metal cuffs

Interview on 01/13/2015 at 1107 during ED tour with Charge Nurse #1 revealed the only approved restraints used in the ED by nursing staff are "soft limb restraints." Interview revealed "only the Sheriff and Police Departments use handcuffs and shackles with IVC patients." Interview revealed the nurse is responsible for monitoring and assessing the patient when in handcuffs or shackles. Interview revealed the nursing staff is not responsible for applying the handcuffs or shackles.
Interview with ABC Police Officer #1 on 01/14/2015 at 1435 revealed he was responsible for 3 patients under IVC in the ED at this time. The interview revealed he stations himself at an area in the corner. The interview revealed he can observe the patient in the seclusion room and the patient in room #5. The interview revealed Officer #1 was not allowed to answer any further questions. The interview revealed a phone number to two Lieutenant at the City Police Department if further questions needed to be asked.

Interview on 01/15/2015 at 1015 with the ED Medical Director revealed he spoke with a police officer with the ABC City Police Department while in the ED. Interview revealed the police officer stated the Chief of Police had determined that the IVC patients were in the custody of the police officer and that it was Departmental policy for all IVC patients to be placed into handcuffs or shackles while in the ED. Interview revealed "we can't control the police putting the patients in custody." Interview revealed "we can control the monitoring of the patients." The interview revealed " we have been trying to work through this for the past 9 months with Chief of Police."

Interview on 01/15/2015 at 1235 with the ED Nursing Director revealed patients brought into the ED under IVC or who are placed under IVC while in the ED were placed into "forensic" restraints (handcuffs or shackles) by the law enforcement officers. Interview revealed the ED staff did not view the placement of IVC patients in handcuffs or shackles as a restraint, because they were in the custody of law enforcement. Interview revealed
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0168
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based upon policy and procedure reviews, medical record reviews, and staff interviews the hospital's nursing staff failed to obtain a physician's order after placing a patient in restraints in 1 of 1 intensive care unit (ICU) patients (#2).

The findings include:

Review of current hospital policy "Restraint of Patients, PC 17", revised 12/2014, revealed "PURPOSE: The use of restraints is a therapeutic intervention implemented to prevent the patient from injuring himself/herself or from injuring others. The decision to use a restraint is driven by a comprehensive individual assessment. This document is used to provide consistent guidelines for the safe use of chemical and physical restraints and seclusion, if alternatives, as determined by an interdisciplinary team, have proven to be clinically ineffective to provide a safe environment for the patient. ...DEFINITIONS: Restraint - is the direct application of physical force to a patient, with or without the patient's permission, to restrict his or her freedom of movement. The physical force may be human, mechanical devices, or a combination thereof. Physical Restraints - any manual method or physical/mechanical device, material or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely. PROCEDURE FOR USE OF RESTRAINT: Initiation and Renewal of Orders Standing orders, protocols, and/or PRN orders are not permitted. When initiating the use of a restraint, the appropriate restraint physician's order form (Nonviolent or Violent/Self Destructive) must be completed and placed on the chart within 30 minutes. This original order is time-limited based on type of restraint and age of patient. When use of restraints is contemplated, a physician/LIP or RN who has been trained in restraint application must document a face-to-face assessment prior to applying restraints, and document the need for restraint within the 1 hour time frame. The physician's/LIP's order must specify: *the restraint type *the justification for the restraint *date and time ordered *duration ...The in-person evaluation, conducted within one hour of the initiation of restraint or seclusion for the management of violent or self-destructive behavior that jeopardizes the physical safety of the patient, staff or others, includes the following: *an evaluation of the patient's immediate situation *the patient's reaction to the restraint *the patient's medical and behavioral condition *the need to continue or terminate the restraint or seclusion ...The Nonviolent Restraint Physician's Orders: Orders for nonviolent restraints must be renewed each calendar day by the patient's attending physician or other designated LIP based on his or her examination of the patient. It is not necessary for the renewal to be completed within a 24-hour time-frame as the physician can re-evaluate the patient and need for non-violent/self-destructive restraints during routine rounds. If restraints for nonviolent behavior purposes are anticipated to be continued beyond the maximum time limit of the order, a restraint renewal sticker is placed on the physician order form and must be completed by the LIP before the original order expires. Its use is based on his or her face-to-face examination of the patient.

Closed medical record review revealed Patient #2 was admitted on [DATE] with a diagnosis of anemia and gastrointestinal bleeding (GI Bleed). Medical record review revealed on 09/14/2014 at 0700 the patient was placed in soft upper limb restraints with all 4 side rails of the bed in the up position. Medical record review revealed no documentation of a physician order for the restraints.

Interview on 09/14/2015 at 0930 with Regulatory Compliance Officer revealed there was no initial order for the restraint. The interview revealed "There's no order, I don't see any orders for this patient."
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0171
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on hospital policy review, medical record reviews, and staff interviews, the hospital's Emergency Department (ED) staff failed to ensure a physician's restraint order was time limited for no longer than four (4) hours for 1 of 1 adult patients (#9) [AGE] years or older and for no longer than two (2) hours for 1 of 1 child and adolescent patients 9 to 17 years of age (#12) that was restrained or secluded for the management of violent or self-destructive behaviors.

The findings include:

Review of current hospital policy "Restraint of Patients, PC 17", revised 12/2014, revealed "PURPOSE: The use of restraints is a therapeutic intervention implemented to prevent the patient from injuring himself/herself or from injuring others. ...DEFINITIONS: ...Physical Restraints - any manual method or physical/mechanical device, material or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely. ...Restraints for Violent or Self-Destructive Behavior: refers to the use of restraints in those patients who require management of violent or self-destructive behavior towards themselves or others (including caregivers or other patients) or, who require physical restraint to manage suicidal or homicidal behaviors in ANY setting. ...Seclusion - seclusion is the involuntary confinement of a patient alone in a room or area from which the patient is physically prevented from leaving. Seclusion may only be used for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others. The following interventions are not considered seclusion: 1. a patient physically restrained alone in an unlocked room. ...PROCEDURE FOR USE OF RESTRAINT: Initiation and Renewal of Orders Standing orders, protocols, and/or PRN orders are not permitted. When initiating the use of a restraint, the appropriate restraint physician's order form (Nonviolent or Violent/Self Destructive) must be completed and placed on the chart within 30 minutes. This original order is time-limited based on type of restraint and age of patient. ...The physician's/LIP's order must specify: *the restraint type *the justification for the restraint *date and time ordered *duration ...For Violent/Self-Destructive Restraints [V/SD] ..The time limit for Violent/Self-Destructive Restraints is: *4 hours for adults (18 years of age or older) *2 hours for children (ages 9-17) *1 hour for children under age of 9 ...DOCUMENTATION: ...Each episode of restraint/seclusion use is to be recorded in the medical record. Documentation will include: ...*each telephone order received from a physician/LIP ..."

1. Closed medical record review of Patient #12 revealed a 9 (nine) year old child presenting to the Emergency Department with mother on 12/12/2014 at 2001 with a chief complaint of "Pt (patient) with hx (history) of ADHD (Attention Deficient Hyperactivity Disorder) seen by daymark and referred to ER for psych eval. (evaluation). Mother sts (states) pt acting out when not getting 'his way'. Mother sts pt using foul language, and damaging property at home. Pt age appropriate, resp (respirations) even and unlabored, NAD (no acute distress)." Medical record review revealed documentation by nursing staff that triage was conducted at 2003 and the child was alert responded to voice and was oriented to person, time and place. Review of nursing documentation at 2002 revealed the "Pt ambulated to ER-1 - Pt very agitated and uncontrollable. Pt screaming, constantly in motion and tearing up thins at home. Pt using foul language". Medical record review revealed documentation of the physician's medical screening exam (MSE) on 12/12/2014 at 2010 in room 1. Review of the MSE revealed the parent was with the patient during the exam and the child was "angry, frustrated, agitated". Review of the MSE revealed the clinical impression by the physician was ADHD. Review of nursing documentation revealed at 2140 the patient was"very agitated - screaming, rolling around on floor, slapping at wall and not following instructions. Medical record review revealed the patient was administered per physician's order Ativan (medication for treatment of anxiety disorders) 1 mg IM at 2219 and Benadryl 25 (medication used for psychiatric symptoms) mg IM at 2213. Medical record review revealed documentation on the "Appropriateness/Justification for Acute Medical/Surgical Restraint" form of a physician's order for the patient to be physically restrained due to "Pt's (patient's) behavior uncontrollable - spitting, scratching- trying to bite, cursing- uncontrollable with meds." Further review of the physician's order for restraint revealed the restraint type was ordered "Soft limb holders...Four Side Rails". Review of the type order revealed no documentation of which limbs or how many limbs were to be restrained. Review of the order revealed the restraint was initiated on 12/12/2014 at 2248 and the order was signed by the physician at 2250. Review of the order did not reveal any documentation of the time limit for restraining the child.

Interview on 01/15/2015 at 1235 with the ED Nursing Director revealed patients brought into the ED under IVC or who are placed under IVC while in the ED were placed into "forensic" restraints (handcuffs or shackles) by the law enforcement officers. Interview revealed the ED staff did not view the placement of IVC patients in handcuffs or shackles as a restraint, because they were in the custody of law enforcement. Interview revealed there would not be any documentation of a physician's order for restraint because ED physician's do not order forensic restraints and the handcuffs and shackles were not considered a restrictive intervention by ED staff. Interview confirmed the documentation of the physician's order for restraint signed by the ED physician on 12/12/2014 at 2250. Interview confirmed the order was not time limited up to 2 hours for children or adolescents age 9 to 17 years of age. Interview confirmed the ED staff did not follow the hospital's Restraint of Patient policy for time limited restraint orders.




2. Closed medical record review on 01/14/2015 for Patient #9, revealed an [AGE] year old male who presented to the hospital's ED on 11/01/2013 at 1106 via private transportation accompanied by group home staff. Review revealed the patient's chief complaint (cc) was Crisis Evaluation Referral. Review of triage nurse documentation at 1116 revealed "pt admitted to new group home Monday, staff reports pt made threats to 'kill himself and everybody else.' Stated pt attempted to run away." Review of initial nursing assessment documentation revealed the patient was alert, awake, responsive to voice, oriented to person, time, and place. Review of a ED risk screen revealed the patient was assessed as "No" for risk for self harm/elopement. Review revealed the patient was evaluated by a ED physician at 1109. Review revealed a chief complaint of suicidal thoughts, expressing SI (suicidal ideation) and HI (homicidal ideation). Review revealed a past medical history of bipolar disorder, schizophrenia, and moderate mental retardation (MR). Review revealed the patient was assessed as no acute distress; awake and alert; oriented X4 (person, place, time, and situation); mood and affect normal. Extremities non-tender and no signs of injury. Review of a Affidavit and Petition For Involuntary Commitment form dated 11/01/2013 (note timed) revealed the Respondent was Patient #9 and the Petitioner was ED Physician A. Review revealed "The facts upon which this opinion is based are as follows....Patient is mentally challenged with history of Bipolar D/O (disorder) and Schizophrenia who is very unstable at this time. He is making threats that he will kill others at the group home and himself." Review of a "Findings and Custody Order Involuntary Commitment" revealed the order was signed on 11/01/2013 at 1258 by a Magistrate. Review revealed "The Court finds from the petition in the above matter that there are reasonable grounds to believe that the facts alleged in the petition are true and that the respondent (Patient #9) is probably: [X] 1. mentally ill and dangerous to self or others...." Review revealed the respondent was taken into custody by ABC City Police Officer on 11/01/2013 at 1336 (Patient in ED when taken into custody). Review of a Computerized Physician's Order Entry (CPOE) report, Order # 26, CPOE # 2, revealed a physician's order entered by ED Physician A on 11/01/2013 at 1358 for "Restraints, Place in", Frequency: "ONCE", Priority: "Routine". Review of nursing documentation revealed on 11/01/2013 at 1106 "Pt cc HI. Pt @ (at) group home. MR high functioning w (with)/Psychosis + (and) Bipolar. Pt pretending to shoot staff + 'flipping off' other patients from room." At 1245, "Pt moved to isolation room, IVC in place, officer @ bedside. Pt acting iriatic [sic], cuffed (restraint) to bed, Pt had previously tried to hang self w/belt. Now threatening officer + trying to bite him, Pt trying to break free from cuffs, bed now broken, officer warning pt of violent behavior." At 1400, "Pt out of control, violent, calling everyone 'F**king Bi**hs.' Broke posey chest vest....threatening to kill officer. Pt sprayed w/pepper spray @ close range." At 1410, "Pt refusing flushing treatment. V/S (vital signs) WNL (within normal limits), resting in bed with eyes open, resp (respirations) nonlabored." Review of a Comprehensive Assessment Tool-Intake form dated 11/01/2013 at 1452 revealed "...presents to (Hospital A) - ED c (with) group staff. Staff from group home report clt (client) was trying to run away this am and threatened to kill self as well as staff. Upon admission clt was making a gun with his fingers and placing it to the head of staff, threatening to stab another staff c a plastic fork and being verbally abusive. ...Clt was restrained on admission c forensic restraints and required pepper spray p (after) refusing chemical restraint. ..." Review of nursing documentation revealed at 1600, "Pt starting to yell out again, HPD (ABC City Police Department) at bedside." At 1755, "Pt resp WNL..." Review of Crisis Assessment documentation by mobile crisis management staff for Patient #9 dated 11/01/2013 at 1800 revealed the reason for referral was physical aggression, property destruction, threats of physical aggression, running away, verbal aggression, hallucinations or delusions, homicidal and suicidal. Review revealed "Became aggressive at GH (group home). Threatened to stab + shoot self + others. Ran to neighbors. Upon entering ED he refused meds + put a belt around his neck. He had to be pepper sprayed + put in 4 point restraints. ..." Review of mental status examination revealed the patient was disheveled with poor hygiene, and in 4 point restraints. Review of nursing documentation revealed at 1900, "...Pt sleeping on bed in 4 point restraints. HPD c (with) patient." Record review failed to reveal documentation the CPOE order entered by ED Physician A on 11/01/2013 at 1358 for restraints was time limited up to 4 hours for adults 18 years of age or older for Patient #9.

Interview on 01/15/2015 at 1235 with the ED Nursing Director revealed patients brought into the ED under IVC or who are placed under IVC while in the ED were placed into "forensic" restraints (handcuffs or shackles) by the law enforcement officers. Interview revealed the ED staff did not view the placement of IVC patients in handcuffs or shackles as a restraint, because they were in the custody of law enforcement. Interview revealed there would not be any documentation of a physician's order for restraint because ED physician's do not order forensic restraints and the handcuffs and shackles were not considered a restrictive intervention by ED staff. Interview confirmed the documentation of the CPOE order for restraint entered by ED Physician A on 11/01/2013 at 1358. Interview confirmed the order was not time limited up to 4 hours for adults [AGE] years of age or older. Interview revealed "at the time we were using paper and not CPOE, I can't explain why there is a CPOE order" for restraint Interview confirmed the ED staff did not follow the hospital's Restraint of Patient policy for time limited restraint orders.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0175
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based upon hospital policy and procedure reviews, observations during tours, medical record reviews, Law Enforcement Officer (LEO) interviews, staff and physician interviews, the hospital's nursing staff failed to provide ongoing assessment and monitoring of the condition of a patient during restraint or seclusion for 6 of 6 emergency department (ED) patients (#14, #16, #13, #17, #12, #9) under involuntary commitment (IVC) and 1 of 1 intensive care unit (ICU) patients not under IVC (#2).

The findings include:

Review of current hospital policy "Restraint of Patients, PC 17", revised 12/2014, revealed "PURPOSE: The use of restraints is a therapeutic intervention implemented to prevent the patient from injuring himself/herself or from injuring others. The decision to use a restraint is driven by a comprehensive individual assessment. ...DEFINITIONS: Restraint - is the direct application of physical force to a patient, with or without the patient's permission, to restrict his or her freedom of movement. The physical force may be human, mechanical devices, or a combination thereof. Physical Restraints - any manual method or physical/mechanical device, material or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely. ...Restraint to Promote Medical Recovery (non-violent): refers to the use of restraints in those patients who require various medically essential therapies while hospitalized and who demonstrate a state of confusion or altered cognition that puts those therapies at risk OR those patients who require management of non-psychiatric behaviors that put them at risk for injury. Restraints for Violent or Self-Destructive Behavior: refers to the use of restraints in those patients who require management of violent or self-destructive behavior towards themselves or others (including caregivers or other patients) or, who require physical restraint to manage suicidal or homicidal behaviors in ANY setting. ...Restrictive Devices Applied by Law Enforcement Officials - handcuffs and other restrictive devices applied by law enforcement officials for custody, detention, and public safety reasons and is not involved in the provision of health care; not considered restraints. ...Seclusion - seclusion is the involuntary confinement of a patient alone in a room or area from which the patient is physically prevented from leaving. Seclusion may only be used for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others. The following interventions are not considered seclusion: 1. a patient physically restrained alone in an unlocked room. ...POLICY: It is the policy of (Hospital name) Medical Center to: 1. Prevent, reduce and eliminate the use of restraints by: a. preventing emergencies that have the potential to lead to the use of restraints, b. limiting the use of restraints to emergencies where there is a risk of the patient harming himself/herself or others. c. using the least restrictive method. 2. Protect the patient and preserve the patient's rights, dignity and well being during restraint use by: a. respecting the patient as an individual; b. maintaining a clean and safe environment; ...d. maintaining the patient's modesty, preventing visibility to others, and maintaining comfortable body temperature is maintained. 3. Provide for safe application and removal of the restraint by qualified staff. 4. Monitor and meet the patient's needs while in restraints. 5. Re-assess and encourage release of restraints as soon as possible. ...Restraints will be used only in situations where the patient is demonstrating observable behaviors that indicate he/she is at risk of injuring himself/herself or others. Restraints are not to be used for punishment, coercion, discipline, or retaliation of the patient or for staff convenience. This policy does not apply to devices....used by law enforcement officials although the standards of care stated within this document may be applicable. ...LEAST RESTRICTIVE RESTRAINT/SAFE APPLICATION: Assessment and reassessment processes should include the appropriateness of the choice of restraint and/or seclusion. Physical restraints will be loosened periodically to evaluate skin integrity and circulation while the patient is in restraints. ...Discontinuing Restraint Once restraint is applied or initiated, the patient should be monitored and evaluated for the continued need of the intervention and the continued appropriateness of the type of intervention. ...The restraint should be discontinued as soon as the patient meets the behavior criteria for its discontinuation. The assessment of the continued need for restraint to determine early release should be documented at a minimum of every two hours or more often as the patient's condition improves. ...MONITORING, ASSESSING, AND CARE OF THE PATIENT IN RESTRAINTS: When restraints are used there is an increased need for patient monitoring and assessment to assure patient safety, that the less restrictive methods are used when possible, and that restraint is discontinued as soon as possible. Immediately after restraints are applied an assessment should be made to ensure that the restraints were properly and safely applied so as to not cause the patient harm or pain. Documentation should include this assessment as well as the patient's response, any adjustments made. The frequency of monitoring the patient must be made on an individual basis, which includes a rationale that reflects consideration of the individual patient's medical needs and health status. The assessment includes, as appropriate to the type of restraint used: *signs of injury associated with the restraints *nutrition/hydration *circulation and range of motion in the extremities *vital signs *hygiene and elimination *physical and psychological status and comfort (i.e. skin integrity, comfortable body temperature, the patient's dignity, mental status, and emotional well being) *readiness for release from restraints *patient's understanding of the reasons for restraint and requirements for release ...PATIENT/FAMILY EDUCATION: ...For Non-Violent restraints, reassessment and documentation is required at least every 2 hours and for Violent/Self-Destructive restraints, it is required every 15 minutes.

Interview on 01/14/2015 at 1420 during tour of the ED (1420-1500) with the Charge Nurse #2 revealed the ED had three (3) patients currently under involuntary commitment (IVC) in exam rooms #1, #5, #17 and one (1) patient pending IVC in exam room #7.

1. Observation during ED tour on 01/14/2015 at 1427 of exam room #17, revealed the room was located across from the nursing station. Observation revealed the room had a sliding glass door. Observation revealed a male patient (Patient #14) wearing green disposable scrubs and sitting on the end of the stretcher leaning over a bedside table. Observation revealed the stretcher's two side rails were up and in the locked position. Observation revealed the patient was alert, calm, and cooperative. Observation revealed the patient's right leg/ankle was chained to the stretcher's frame with a metal shackle/cuff (restraint). Observation revealed the patient did not exhibit any violent or self-destructive behaviors. Observation revealed the patient was in the exam room alone and without direct supervision of a LEO. At 1433, observation revealed Patient #14 stood up off the end of the stretcher and pivoted around to the side of the stretcher without difficulty or assistance. At 1434, observation revealed XYZ County Sheriff Deputy (CSD) #1 was sitting behind the nursing station in a cubical. Observation revealed the cubical was on the opposite side of the nursing station, away from exam room #17. Observation revealed CSD #1 stood up and exited the cubical and walked down the hallway on the opposite side of the nursing station, away from exam room #17 and exited the emergency department treatment area through a set of double doors. Observation revealed Patient #14 was alone in exam room #17 unsupervised by a LEO. At 1436, observation revealed CSD #1 returned to the cubical in the nursing station and sat down. Observations from 1427 to 1500 failed to observe any violent or self-destructive behaviors exhibited by Patient #14 while being restrained in exam room #17.

Open medical record review on 01/14/2015 revealed Patient #14, a [AGE] year old male presented to the hospital's ED on 01/13/2015 at 1820 accompanied by Law Enforcement under IVC petition. Review revealed the patient's chief complaint was IVC-Crisis Evaluation Referral. Review of triage nurse documentation at 1827 revealed "IVC, per caregiver pt (patient) with bizarre behavior, pt walking around showing gentials [sic], pt endorses auditory hallucinations, pt with rambling thoughts in triage, pt states he will only hurt someone if they try to hurt him." Review of triage assessment documentation revealed the patient was alert, oriented x 3 (person, place, time) and anxious. Review revealed the patient was evaluated by a physician at 1908. Review revealed a chief complaint of being agitated and exposing genitals. Review revealed the patient was assessed as no acute distress, awake and alert, slightly agitated, pressured speech, and directable. Review revealed the patient was "cooperative." Review of a "Findings and Custody Order Involuntary Commitment" revealed the order was signed on 01/13/2015 at 1541 by a Magistrate. Review revealed "The Court finds from the petition in the above matter that there are reasonable grounds to believe that the facts alleged in the petition are true and that the respondent (Patient #14) is probably: [X] 1. mentally ill and dangerous to self or others or mentally ill and in need of treatment in order to prevent further disability or deterioration that would predictably result in dangerousness. ..." Review of an "Examination and Recommendation to Determine Necessity for Involuntary Commitment" form dated 01/13/2015 at 2345 revealed "Description of Findings" with "...presenting for agitation, exposing himself inappropriately to others. On evaluation, pt is disorganized with pressured speech. Oriented to location but not situation. Is currently a danger to himself due to psychosis." Review of nursing documentation at 2235 revealed "Resting quietly in bed. No aggressive behaviors, no self-injurious behavior. ..." At 1215 (01/14/2015) "...Pt unshackled while bed was exchanged." At 1330 "Pt sitting at end of bed. No c/o voiced. No distress noted." At 1500 "Pt sitting on bed c (with) no distress noted." At 1845 "Pt transported to (hospital name)....ambulated to police care no distress noted." Review of "Suicide Precautions Flow sheet" documentation on 01/13/2015 from 1900 to 2300 and 01/14/2015 from 0715 to 1845 revealed the patient's behavior was documented by staff as calm or cooperative. Review revealed no documentation the patient was violent or aggressive. Review revealed on 01/14/2015 at 1430, 1445, and 1500 (corresponding timeframe to Surveyor's observation [1427-1500] of the patient cuffed/shackled to the stretcher) as being cooperative. Record review failed to reveal any available documentation Patient #14 exhibited violent or self-destructive behaviors necessitating the need for restraint use while hospitalized from [DATE] at 1820 through discharge on 01/14/2015 at 1845. Further record review failed to reveal documentation of ongoing monitoring and assessment of the patient at least every 15 minutes for violent/self-destructive restraint or every two hours for non-violent restraint (as appropriate to the type of restraint used) for one or more of the following: signs of injury associated with the restraints, nutrition/hydration, circulation and range of motion in the extremities, vital signs, hygiene and elimination, physical and psychological status and comfort (i.e. skin integrity, comfortable body temperature, the patient's dignity, mental status, and emotional well being), readiness for release from restraints, patient's understanding of the reasons for restraint and requirements for release, per hospital policy.

Interview on 01/13/2015 at 1107 during ED tour with Charge Nurse #1 revealed the only approved restraints used in the ED by nursing staff are "soft limb restraints." Interview revealed "only the Sheriff and Police Departments use handcuffs and shackles with IVC patients." Interview revealed the nurse is responsible for monitoring and assessing the patient when in handcuffs or shackles. Interview revealed the nursing staff is not responsible for applying the handcuffs or shackles.

Interview on 01/14/2015 at 1442 with CSD #1 revealed he was a Deputy Sheriff with the XYZ County Sheriff's Department. Interview revealed he was present in the ED for a "10-73" (mental subject). Interview revealed the patient (#14) in exam room #17 was under IVC. Interview revealed the patient was brought to the ED on 01/13/2015. Interview revealed he relieved the previous Deputy this morning (01/14/2015) at shift change. Interview revealed the previous Deputy placed the patient into "ankle shackles." Interview revealed the "officer makes the decision wither or not the patient needs to be handcuffed or shackled." Interview revealed Patient #14 was not going to jail and was not under arrest. Interview revealed he (CSD #1) was on standby until a mental health facility could be found for the patient. Interview revealed because the patient was in his custody, he was responsible for any of the patient's actions. Interview revealed when the patient complains the cuffs/shackles are too tight or hurting, he will use 2-3 fingers to check to see if the cuffs/shackles are too tight. Interview revealed there was no set schedule for periodically removing the cuffs/shackles or checking for tightness. Interview revealed the "patient lets me know if they are too tight." Interview revealed if the patient needed to go to the restroom, the cuffs/shackles are removed. Interview revealed he does not check pulses or skin for circulation. Interview revealed the nurse is responsible for taking care of the patient's medical needs. Interview revealed he does not document in the patients ED medical record.

Interview on 01/15/2015 at 1015 with the ED Medical Director revealed he spoke with a police officer with the ABC City Police Department while in the ED. Interview revealed the police officer stated the Chief of Police had determined that the IVC patients were in the custody of the police officer and that it was Departmental policy for all IVC patients to be placed into handcuffs or shackles while in the ED. Interview revealed "we can't control the police putting the patients in custody." Interview revealed "we can control the monitoring of the patients." The interview revealed " we have been trying to work through this for the past 9 months with Chief of Police."

Interview on 01/15/2015 at 1235 with the ED Nursing Director revealed patients brought into the ED under IVC or who are placed under IVC while in the ED were placed into "forensic" restraints (handcuffs or shackles) by the law enforcement officers. Interview revealed the ED staff did not view the placement of IVC patients in handcuffs or shackles as a restraint, because they were in the custody of law enforcement. Interview revealed there would not be any documentation of monitoring and assessment every 15 minutes (for violent self-destructive behavior) and/or 2 hours (for non-violent behavior), because the handcuffs and shackles were not considered a restrictive intervention by ED staff. Interview revealed the ED staff did not follow the hospital's Restraint of Patient policy for monitoring Patient #14 while he was restrained in the ED with metal cuffs/shackles placed by a law enforcement officer.

2. Observation during ED tour on 01/14/2015 at 1438 of exam room #5, revealed the room was located diagonally across from the nursing station. Observation revealed the room had a wood door. Observation revealed a female patient (Patient #16) wearing green disposable scrubs and laying on her left side on the stretcher, watching television. Observation revealed the stretcher's two side rails were up and in the locked position. Observation revealed the patient was alert, calm, and cooperative. Observation revealed the patient's left wrist was chained to the stretcher's frame with a metal cuff/shackle (restraint). Observation revealed the patient did not exhibit any violent or self-destructive behaviors. Observation revealed the patient was in the exam room alone and without direct supervision of a LEO. Observation revealed an ABC City Police Department officer was sitting behind the nursing station in a cubical, reading a magazine. Observations from 1438 to 1500 failed to observe any violent or self-destructive behaviors exhibited by Patient #16 while being restrained in exam room #5.

Open medical record review on 01/15/2015 for Patient #16 revealed an [AGE] year old female presented to the Hospital's ED on 01/13/2015 at 1726 for "potential drug overdose." Review revealed the patient was triaged by a RN at 1732 and was assessed by a ED Physician at 1734. Review revealed the patient was assessed at 1912 by a mobile crisis worker. Review revealed on 01/14/2015 at 0050, the patient was IVC for being mentally ill and dangerous to self and others. Review revealed at 0200 and 0400, the patient's behavior was documented as asleep with parent and LEO at bedside. Review revealed from 0600 to 01/15/2015 at 0515, the patient's behavior was documented as asleep, tearful, and resting quietly in bed, resting in bed with eyes closed and laying in bed with eyes closed. Review revealed at 0536, the patient requested the "shackle" (restraint) be loosened and the hospital staff informed the LEO. Review revealed at 0725, the patient behavior was documented as alert and oriented with right lower extremity "cuffed" (restraint) to bed frame. Review revealed at 0835, the patient was transferred to a Psychiatric hospital. Record review failed to reveal any available documentation Patient #16 exhibited violent or self-destructive behaviors necessitating the need for restraint use while hospitalized from [DATE] at 1726 through discharge on 01/15/2015 at 0835. Further record review failed to reveal documentation of ongoing monitoring and assessment of the patient at least every 15 minutes for violent/self-destructive restraint or every two hours for non-violent restraint (as appropriate to the type of restraint used) for one or more of the following: signs of injury associated with the restraints, nutrition/hydration, circulation and range of motion in the extremities, vital signs, hygiene and elimination, physical and psychological status and comfort (i.e. skin integrity, comfortable body temperature, the patient's dignity, mental status, and emotional well being), readiness for release from restraints, patient's understanding of the reasons for restraint and requirements for release, per hospital policy.

Interview on 01/13/2015 at 1107 during ED tour with Charge Nurse #1 revealed the only approved restraints used in the ED by nursing staff are "soft limb restraints." Interview revealed "only the Sheriff and Police Departments use handcuffs and shackles with IVC patients." Interview revealed the nurse is responsible for monitoring and assessing the patient when in handcuffs or shackles. Interview revealed the nursing staff is not responsible for applying the handcuffs or shackles.

Interview with ABC Police Officer #1 on 01/14/2015 at 1435 revealed he was responsible for 3 patients under IVC in the ED at this time. The interview revealed he stations himself at an area in the corner. The interview revealed he can observe the patient in the seclusion room and the patient in room #5. The interview revealed Officer # 1 was not allowed to answer any further questions. The interview revealed a phone number to two Lieutenant at the City Police Department if further questions needed to be asked.

Interview on 01/15/2015 at 1015 with the ED Medical Director revealed he spoke with a police officer with the ABC City Police Department while in the ED. Interview revealed the police officer stated the Chief of Police had determined that the IVC patients were in the custody of the police officer and that it was Departmental policy for all IVC patients to be placed into handcuffs or shackles while in the ED. Interview revealed "we can't control the police putting the patients in custody." Interview revealed "we can control the monitoring of the patients." The interview revealed " we have been trying to work through this for the past 9 months with Chief of Police."

Interview on 01/15/2015 at 1235 with the ED Nursing Director revealed patients brought into the ED under IVC or who are placed under IVC while in the ED were placed into "forensic" restraints (handcuffs or shackles) by the law enforcement officers. Interview revealed the ED staff did not view the placement of IVC patients in handcuffs or shackles as a restraint, because they were in the custody of law enforcement. Interview revealed there would not be any documentation of monitoring and assessment every 15 minutes (for violent self-destructive behavior) and/or 2 hours (for non-violent behavior), because the handcuffs and shackles were not considered a restrictive intervention by ED staff. Interview revealed the ED staff did not follow the hospital's Restraint of Patient policy for monitoring Patient #16 while she was restrained in the ED with metal cuffs/shackles placed by a law enforcement officer.

3. Observation during ED tour on 01/14/2015 at 1430 of exam room #1, revealed an ante room was located diagonally across from the nursing station. Observation revealed the room was an isolation room. Observation revealed to view a patient required walking into the ante room, turning right and proceeding approximately 4 feet to enter the isolation room proper. Observation revealed a male patient (Patient #13) wearing green disposable scrubs and laying supine on the stretcher with both hands across his abdomen. Observation revealed the stretcher's two side rails were up. Observation revealed the patient was alert, calm, and cooperative. Observation revealed the patient's right ankle was chained to the stretcher's frame with a metal cuff/shackle (restraint). Observation revealed the patient did not exhibit any violent or self-destructive behaviors. Observation revealed the patient was in the isolation room alone and without direct supervision of a LEO. Observation revealed an ABC City Police Department officer was sitting behind the nursing station in a cubical and due to location he could not observe the patient. Observation revealed from the LEO's location the ante room could be observed only. Observations from 1430 to 1500 failed to observe any violent or self-destructive behaviors exhibited by Patient #16 while being restrained in exam room #7.

Open medical record review on 01/14/2015 for Patient #13 revealed a [AGE] year old male presented to the hospital ED (Emergency Department) on 01/13/2015 at 0125 with thoughts of suicide and for substance abuse detoxification. Review revealed at 0127, the patient was triaged by a RN and at 0234, the patient was assessed by a ED Physician. Review revealed at 0840, the patient was assessed by a mobile crisis worker and was admitted for suicidal thoughts. Review revealed at 1600, the patient was IVC (Involuntary Commitment) due to mentally ill and dangerous to self and others. Further review revealed when the patient was IVC, LEO (Law Enforcement Officer) placed the patient in leg shackles. Review revealed at 1800 and 2000, the patient's behavior was documented as calm and resting with eyes closed with the right ankle in shackled (restraint). Review revealed on 01/14/2015 at 0000, 0200, 0430, 0600, 0735 and 0935, the patient behavior was documented as asleep and resting quietly with the right ankle shackled. Review revealed at 1645, the patient was transferred to a Psychiatric hospital for treatment. Review revealed no documentation the patient demonstrated violent or self-destructive behaviors. Record review failed to reveal any available documentation Patient #13 exhibited violent or self-destructive behaviors necessitating the need for restraint use while hospitalized from [DATE] at 0125 through discharge on 01/14/2015 at 1645.

Interview on 01/13/2015 at 1107 during ED tour with Charge Nurse #1 revealed the only approved restraints used in the ED by nursing staff are "soft limb restraints." Interview revealed "only the Sheriff and Police Departments use handcuffs and shackles with IVC patients." Interview revealed the nurse is responsible for monitoring and assessing the patient when in handcuffs or shackles. Interview revealed the nursing staff is not responsible for applying the handcuffs or shackles.

Interview with ABC Police Officer #1 on 01/14/2015 at 1435 revealed he was responsible for 3 patients under IVC in the ED at this time. The interview revealed he stations himself at an area in the corner. The interview revealed he can observe the patient in the seclusion room and the patient in room #5. The interview revealed Officer # 1 was not allowed to answer any further questions. The interview revealed a phone number to two Lieutenant at the City Police Department if further questions needed to be asked.

Interview on 01/15/2015 at 1015 with the ED Medical Director revealed he spoke with a police officer with the ABC City Police Department while in the ED. Interview revealed the police officer stated the Chief of Police had determined that the IVC patients were in the custody of the police officer and that it was Departmental policy for all IVC patients to be placed into handcuffs or shackles while in the ED. Interview revealed "we can't control the police putting the patients in custody." Interview revealed "we can control the monitoring of the patients." The interview revealed " we have been trying to work through this for the past 9 months with Chief of Police."

Interview on 01/15/2015 at 1235 with the ED Nursing Director revealed patients brought into the ED under IVC or who are placed under IVC while in the ED were placed into "forensic" restraints (handcuffs or shackles) by the law enforcement officers. Interview revealed the ED staff did not view the placement of IVC patients in handcuffs or shackles as a restraint, because they were in the custody of law enforcement. Interview revealed there would not be any documentation of monitoring and assessment every 15 minutes (for violent self-destructive behavior) and/or 2 hours (for non-violent behavior), because the handcuffs and shackles were not considered a restrictive intervention by ED staff. Interview revealed the ED staff did not follow the hospital's Restraint of Patient policy for monitoring Patient #13 while he was restrained in the ED with metal cuffs/shackles placed by a law enforcement officer.

4. Observation during ED tour on 01/14/2015 at 1430 of the seclusion room #7 revealed a room with a solid wood door and window with blinds and the blinds were outside covering the window. Observation revealed on the left side of the room at the head of the stretcher a metal plate with two sharp pointed corners partially attached to the wall. Observation revealed the metal plate could be easily pulled further off of the wall. When exiting the room a male patient (Patient #17) was observed standing calmly beside with door EMS personnel at his side. Observation revealed the patient was escorted into the seclusion room along with the Mental Health Nurse (MHRN). Approximately 10 minutes 2 City LEOs were observed entering the seclusion room and the MHRN standing out side of the room. The door and the blinds were closed. Interview with the MHRN during the observation revealed City LEO were in the room searching the patient, putting the patient in scrubs and cuffing the patient. The interview revealed the LEO cuffed the patient because the patient was IVC. The interview revealed that even if the patient is calm and cooperative the patient is always cuffed. The interview revealed the MHRN had training on the Hospital policy and procedure for restraining patients in October, 2014. The interview revealed she was also aware of the revision of the restraint and seclusion policy completed in December, 2014. Patient #17 was observed during the interview with both wrist cuffed with metal cuffs

Interview on 01/13/2015 at 1107 during ED tour with Charge Nurse #1 revealed the only approved restraints used in the ED by nursing staff are "soft limb restraints." Interview revealed "only the Sheriff and Police Departments use handcuffs and shackles with IVC patients." Interview revealed the nurse is responsible for monitoring and assessing the patient when in handcuffs or shackles. Interview revealed the nursing staff is not responsible for applying the handcuffs or shackles.
Interview with ABC Police Officer #1 on 01/14/2015 at 1435 revealed he was responsible for 3 patients under IVC in the ED at this time. The interview revealed he stations himself at an area in the corner. The interview revealed he can observe the patient in the seclusion room and the patient in room #5. The interview revealed Officer # 1 was not allowed to answer any further questions. The interview revealed a phone number to two Lieutenant at the City Police Department if further questions needed to be asked.

Interview on 01/15/2015 at 1015 with the ED Medical Director revealed he spoke with a police officer with the ABC City Police Department while in the ED. Interview revealed the police officer stated the Chief of Police had determined that the IVC patients were in the custody of the police officer and that it was Departmental policy for all IVC patients to be placed into handcuffs or shackles while in the ED. Interview revealed "we can't control the police putting the patients in custody." Interview revealed "we can control the monitoring of the patients." The interview revealed " we have been trying to work through this for the past 9 months with Chief of Police."

Interview on 01/15/2015 at 1235 with the ED Nursing Director revealed patients brought into the ED under IVC or who are placed under IVC while in the ED were placed into "forensic" restraints (handcuffs or shackles) by the law enforcement officers. Interview revealed the ED staff did not view the placement of IVC patients in handcuffs or shackles as a restraint, because they were in the custody of law enforcement. Interview revealed there would not be any documentation of monitoring and assessment every 15 minutes (for violent self-destructive behavior) and/or 2 hours (for non-violent behavior), because the handcuffs and shackles were not considered a restrictive intervention by ED staff. Interview revealed the ED staff did not follow the hospital's Restraint of Patient policy for monitoring patients while restrained in the ED with metal cuffs/shackles placed by a law enforcement officer.

5. Closed medical record review of Patient #12 revealed a 9 (nine) year old child presenting to the Emergency Department with mother on 12/12/2014 at 2001 with a chief complaint of "Pt (patient) with hx (history) of ADHD (Attention Deficient Hyperactivity Disorder) seen by daymark and referred to ER for psych eval. (evaluation). Mother sts (states) pt acting out when not getting 'his way'. Mother sts pt using foul language, and damaging property at home. Pt age appropriate, resp (respirations) even and unlabored, NAD (no acute distress)." Medical record review revealed documentation by nursing staff that triage was conducted at 2003 and the child was alert responded to voice and was oriented to person, time and place. Review of nursing documentation at 2002 revealed the "Pt ambulated to ER-1 - Pt very agitated and uncontrollable. Pt screaming, constantly in motion and tearing up thins at home. Pt using foul language". Medical record review revealed documentation of the physician's medical screening exam (MSE) on 12/12/2014 at 2010 in room 1. Review of the MSE revealed the parent was with the patient during the exam and the child was "angry, frustrated, agitated". Review of t
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0178
Based on hospital policy and procedure reviews, medical record reviews and staff interviews, the hospital's Emergency Department (ED) staff failed to ensure a 1-hour face-to-face evaluation was performed by a qualified physician or other licensed independent practitioner (LIP) or trained Registered Nurse (RN) after the initiation of restraint for 2 of 2 patients restrained in the ED for management of violent or self-destructive behaviors (#12, #9).

The findings include:

Review of current hospital policy "Restraint of Patients, PC 17", revised 12/2014, revealed "PURPOSE: The use of restraints is a therapeutic intervention implemented to prevent the patient from injuring himself/herself or from injuring others. ...DEFINITIONS: ...Restraints for Violent or Self-Destructive Behavior: refers to the use of restraints in those patients who require management of violent or self-destructive behavior towards themselves or others (including caregivers or other patients) or, who require physical restraint to manage suicidal or homicidal behaviors in ANY setting. ...PROCEDURE FOR USE OF RESTRAINT: Initiation and Renewal of Orders ...When use of restraints is contemplated, a physician/LIP or RN who has been trained in restraint application must document a face-to-face assessment prior to applying restraints, and document the need for restraint within the 1 hour time frame. ...The in-person evaluation, conducted within one hour of the initiation of restraint or seclusion for the management of violent or self-destructive behavior that jeopardizes the physical safety of the patient, staff or others, includes the following: *an evaluation of the patient's immediate situation *the patient's reaction to the restraint *the patient's medical and behavioral condition *the need to continue or terminate the restraint or seclusion. ...For Violent/Self-Destructive Restraints [V/SD] A physician/LIP or trained RN must document a face-to-face assessment within 1 hour of implementation of restraint or seclusion. The 1-hour face-to-face evaluation includes both a physical and behavioral assessment of the patient that must be conducted by a qualified practitioner within the scope of their practice. An evaluation of the patient's medical condition would include a complete review of systems assessment, behavioral assessment, as well as review and assessment of the patient's history, drugs and medications, most recent lab results, etc. The purpose is to complete a comprehensive review of the patient's condition to determine if other factors, such as drug or medication interactions, electrolyte imbalances, hypoxia, sepsis, etc., are contributing to the patient's violent or self-destructive behavior. During the face-to-face assessment, the qualified practitioner will evaluate the patient's immediate situation, the patient's reaction to the intervention, the patient's medical and behavioral condition; and the need to continue or terminate the restraint or seclusion. ..."

1. Closed medical record review of Patient #12 revealed a 9 (nine) year old child presenting to the Emergency Department with mother on 12/12/2014 at 2001 with a chief complaint of "Pt (patient) with hx (history) of ADHD (Attention Deficient Hyperactivity Disorder) seen by daymark and referred to ER for psych eval. (evaluation). Mother sts (states) pt acting out when not getting 'his way'. Mother sts pt using foul language, and damaging property at home. Pt age appropriate, resp (respirations) even and unlabored, NAD (no acute distress)." Medical record review revealed documentation by nursing staff that triage was conducted at 2003 and the child was alert responded to voice and was oriented to person, time and place. Review of nursing documentation at 2002 revealed the "Pt ambulated to ER-1 - Pt very agitated and uncontrollable. Pt screaming, constantly in motion and tearing up thins at home. Pt using foul language". Medical record review revealed documentation of the physician's medical screening exam (MSE) on 12/12/2014 at 2010 in room 1. Review of the MSE revealed the parent was with the patient during the exam and the child was "angry, frustrated, agitated". Review of the MSE revealed the clinical impression by the physician was ADHD. Review of nursing documentation revealed at 2140 the patient was"very agitated - screaming, rolling around on floor, slapping at wall and not following instructions. Medical record review revealed the patient was administered per physician's order Ativan (medication for treatment of anxiety disorders) 1 mg IM at 2219 and Benadryl 25 (medication used for psychiatric symptoms) mg IM at 2213. Medical record review revealed documentation on the "Appropriateness/Justification for Acute Medical/Surgical Restraint" form of a physician's order for the patient to be physically restrained due to "Pt's (patient's) behavior uncontrollable - spitting, scratching- trying to bite, cursing- uncontrollable with meds." Further review of the physician's order for restraint revealed the restraint type was ordered "Soft limb holders...Four Side Rails". Review of the type order revealed no documentation of which limbs or how many limbs were to be restrained. Review of the order revealed the restraint was initiated on 12/12/ 2014 at 2248 and the order was signed by the physician at 2250. Review of the order did not reveal any documentation of the time limit for restraining the child. Record review did not reveal any documentation of an one hour face to face evaluation.

Interview on 01/15/2015 at 1235 with the ED Nursing Director revealed patients brought into the ED under IVC or who are placed under IVC while in the ED were placed into "forensic" restraints (handcuffs or shackles) by the law enforcement officers. Interview revealed the ED staff did not view the placement of IVC patients in handcuffs or shackles as a restraint, because they were in the custody of law enforcement. Interview revealed there would not be any documentation of a face-to-face within 1-hour after initiation of restraint for Patient #12 because the handcuffs and shackles were not considered a restrictive intervention by ED staff. Interview confirmed the documentation of the physician's order for restraint signed by the ED physician on 12/12/2014 at 2250. Interview confirmed the ED staff did not follow the hospital's Restraint of Patient policy.

2. Closed medical record review on 01/14/2015 revealed Patient #9 presented to the hospital's ED on 11/01/2013 at 1106 via private transportation accompanied by group home staff. Review revealed the patient's chief complaint (cc) was Crisis Evaluation Referral. Review of triage nurse documentation at 1116 revealed "pt admitted to new group home Monday, staff reports pt made threats to 'kill himself and everybody else.' Stated pt attempted to run away." Review of initial nursing assessment documentation revealed the patient was alert, awake, responsive to voice, oriented to person, time, and place. Review of a ED risk screen revealed the patient was assessed as "No" for risk for self harm/elopement. Review revealed the patient was evaluated by a ED physician at 1109. Review revealed a chief complaint of suicidal thoughts, expressing SI (suicidal ideation) and HI (homicidal ideation). Review revealed a past medical history of bipolar disorder, schizophrenia, and moderate mental retardation (MR). Review revealed the patient was assessed as no acute distress; awake and alert; oriented X4 (person, place, time, and situation); mood and affect normal. Extremities non-tender and no signs of injury. Review of a Affidavit and Petition For Involuntary Commitment form dated 11/01/2013 (note timed) revealed the Respondent was Patient #9 and the Petitioner was ED Physician A. Review revealed "The facts upon which this opinion is based are as follows....Patient is mentally challenged with history of Bipolar D/O (disorder) and Schizophrenia who is very unstable at this time. He is making threats that he will kill others at the group home and himself." Review of a "Findings and Custody Order Involuntary Commitment" revealed the order was signed on 11/01/2013 at 1258 by a Magistrate. Review revealed "The Court finds from the petition in the above matter that there are reasonable grounds to believe that the facts alleged in the petition are true and that the respondent (Patient #9) is probably: [X] 1. mentally ill and dangerous to self or others...." Review revealed the respondent was taken into custody by ABC City Police Officer on 11/01/2013 at 1336 (Patient in ED when taken into custody). Review of a Computerized Physician's Order Entry (CPOE) report, Order # 26, CPOE # 2, revealed a physician's order entered by ED Physician A on 11/01/2013 at 1358 for "Restraints, Place in", Frequency: "ONCE", Priority: "Routine". Review of nursing documentation revealed on 11/01/2013 at 1106 "Pt cc HI. Pt @ (at) group home. MR high functioning w (with)/Psychosis + (and) Bipolar. Pt pretending to shoot staff + 'flipping off' other patients from room." At 1245, "Pt moved to isolation room, IVC in place, officer @ bedside. Pt acting iriatic [sic], cuffed (restraint) to bed, Pt had previously tried to hang self w/belt. Now threatening officer + trying to bite him, Pt trying to break free from cuffs, bed now broken, officer warning pt of violent behavior." At 1400, "Pt out of control, violent, calling everyone 'F**king Bi**hs.' Broke posey chest vest....threatening to kill officer. Pt sprayed w/pepper spray @ close range." At 1410, "Pt refusing flushing treatment. V/S (vital signs) WNL (within normal limits), resting in bed with eyes open, resp (respirations) nonlabored." Review of a Comprehensive Assessment Tool-Intake form dated 11/01/2013 at 1452 revealed "...presents to (Hospital A) - ED c (with) group staff. Staff from group home report clt (client) was trying to run away this am and threatened to kill self as well as staff. Upon admission clt was making a gun with his fingers and placing it to the head of staff, threatening to stab another staff c a plastic fork and being verbally abusive. ...Clt was restrained on admission c forensic restraints and required pepper spray p (after) refusing chemical restraint. ..." Review of nursing documentation revealed at 1600, "Pt starting to yell out again, HPD (ABC City Police Department) at bedside." At 1755, "Pt resp WNL..." Review of Crisis Assessment documentation by mobile crisis management staff for Patient #9 dated 11/01/2013 at 1800 revealed the reason for referral was physical aggression, property destruction, threats of physical aggression, running away, verbal aggression, hallucinations or delusions, homicidal and suicidal. Review revealed "Became aggressive at GH (group home). Threatened to stab + shoot self + others. Ran to neighbors. Upon entering ED he refused meds + put a belt around his neck. He had to be pepper sprayed + put in 4 point restraints. ..." Review of mental status examination revealed the patient was disheveled with poor hygiene, and in 4 point restraints. Review of nursing documentation revealed at 1900, "...Pt sleeping on bed in 4 point restraints. HPD c (with) patient." Record review failed to reveal documentation of a 1-hour face-to-face assessment of Patient #9, conducted by a qualified physician/LIP or trained RN within 1 hour (1246 to 1345) after implementation of restraint for violent or self-destructive behaviors on 11/01/2013 at 1245 and within 1 hour (1401-1500) after being sprayed with pepper spray (a weapon) while restrained at 1400; that included the patient's immediate situation, the patient's reaction to the intervention, the patient's medical and behavioral condition; and the need to continue or terminate the restraint or seclusion per hospital policy.

Interview on 01/15/2015 at 1235 with the ED Nursing Director revealed patients brought into the ED under IVC or who are placed under IVC while in the ED were placed into "forensic" restraints (handcuffs or shackles) by the law enforcement officers. Interview revealed the ED staff did not view the placement of IVC patients in handcuffs or shackles as a restraint, because they were in the custody of law enforcement. Interview revealed there would not be any documentation of a face-to-face within 1-hour after initiation of restraint for Patient #9 because the handcuffs and shackles were not considered a restrictive intervention by ED staff. Interview confirmed the documentation of the CPOE order for restraint entered by ED Physician A on 11/01/2013 at 1358. Interview confirmed the ED staff did not follow the hospital's Restraint of Patient policy.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0179
Based on hospital policy review, medical record reviews, and staff interviews the hospital's Emergency Department (ED) staff failed to ensure the physician or other licensed independent practitioner (LIP) or trained RN conducting the face-to-face evaluation within 1 hour after the initiation of restraint evaluated the patient's immediate situation; the patient's reaction to the intervention; the patient's medical and behavioral condition; and the need to continue or terminate the restraint for 2 of 2 patients (#12, #9) restrained for the management of violent or self-destructive behaviors.

The findings include:

Review of current hospital policy "Restraint of Patients, PC 17", revised 12/2014, revealed "PURPOSE: The use of restraints is a therapeutic intervention implemented to prevent the patient from injuring himself/herself or from injuring others. ...DEFINITIONS: ...Restraints for Violent or Self-Destructive Behavior: refers to the use of restraints in those patients who require management of violent or self-destructive behavior towards themselves or others (including caregivers or other patients) or, who require physical restraint to manage suicidal or homicidal behaviors in ANY setting. ...PROCEDURE FOR USE OF RESTRAINT: Initiation and Renewal of Orders ...When use of restraints is contemplated, a physician/LIP or RN who has been trained in restraint application must document a face-to-face assessment prior to applying restraints, and document the need for restraint within the 1 hour time frame. ...The in-person evaluation, conducted within one hour of the initiation of restraint or seclusion for the management of violent or self-destructive behavior that jeopardizes the physical safety of the patient, staff or others, includes the following: *an evaluation of the patient's immediate situation *the patient's reaction to the restraint *the patient's medical and behavioral condition *the need to continue or terminate the restraint or seclusion. ...For Violent/Self-Destructive Restraints [V/SD] A physician/LIP or trained RN must document a face-to-face assessment within 1 hour of implementation of restraint or seclusion. The 1-hour face-to-face evaluation includes both a physical and behavioral assessment of the patient that must be conducted by a qualified practitioner within the scope of their practice. An evaluation of the patient's medical condition would include a complete review of systems assessment, behavioral assessment, as well as review and assessment of the patient's history, drugs and medications, most recent lab results, etc. The purpose is to complete a comprehensive review of the patient's condition to determine if other factors, such as drug or medication interactions, electrolyte imbalances, hypoxia, sepsis, etc., are contributing to the patient's violent or self-destructive behavior. During the face-to-face assessment, the qualified practitioner will evaluate the patient's immediate situation, the patient's reaction to the intervention, the patient's medical and behavioral condition; and the need to continue or terminate the restraint or seclusion. ..."

1. Closed medical record review of Patient #12 revealed a 9 (nine) year old child presenting to the Emergency Department with mother on 12/12/2014 at 2001 with a chief complaint of "Pt (patient) with hx (history) of ADHD (Attention Deficient Hyperactivity Disorder) seen by daymark and referred to ER for psych eval. (evaluation). Mother sts (states) pt acting out when not getting 'his way'. Mother sts pt using foul language, and damaging property at home. Pt age appropriate, resp (respirations) even and unlabored, NAD (no acute distress)." Medical record review revealed documentation by nursing staff that triage was conducted at 2003 and the child was alert responded to voice and was oriented to person, time and place. Review of nursing documentation at 2002 revealed the "Pt ambulated to ER-1 - Pt very agitated and uncontrollable. Pt screaming, constantly in motion and tearing up thins at home. Pt using foul language". Medical record review revealed documentation of the physician's medical screening exam (MSE) on 12/12/2014 at 2010 in room 1. Review of the MSE revealed the parent was with the patient during the exam and the child was "angry, frustrated, agitated". Review of the MSE revealed the clinical impression by the physician was ADHD. Review of nursing documentation revealed at 2140 the patient was"very agitated - screaming, rolling around on floor, slapping at wall and not following instructions. Medical record review revealed the patient was administered per physician's order Ativan (medication for treatment of anxiety disorders) 1 mg IM at 2219 and Benadryl 25 (medication used for psychiatric symptoms) mg IM at 2213. Medical record review revealed documentation on the "Appropriateness/Justification for Acute Medical/Surgical Restraint" form of a physician's order for the patient to be physically restrained due to "Pt's (patient's) behavior uncontrollable - spitting, scratching- trying to bite, cursing- uncontrollable with meds." Further review of the physician's order for restraint revealed the restraint type was ordered "Soft limb holders...Four Side Rails". Review of the type order revealed no documentation of which limbs or how many limbs were to be restrained. Review of the order revealed the restraint was initiated on 12/12/ 2014 at 2248 and the order was signed by the physician at 2250. Review of the order did not reveal any documentation of the time limit for restraining the child. Record review did not reveal any documentation of an one hour face to face evaluation.

Interview on 01/15/2015 at 1235 with the ED Nursing Director revealed patients brought into the ED under IVC or who are placed under IVC while in the ED were placed into "forensic" restraints (handcuffs or shackles) by the law enforcement officers. Interview revealed the ED staff did not view the placement of IVC patients in handcuffs or shackles as a restraint, because they were in the custody of law enforcement. Interview revealed there would not be any documentation of a face-to-face within 1-hour after initiation of restraint for Patient #12 because the handcuffs and shackles were not considered a restrictive intervention by ED staff. Interview confirmed the documentation of the physician's order for restraint signed by the ED physician on 12/12/2014 at 2250. Interview confirmed the ED staff did not follow the hospital's Restraint of Patient policy.

2. Closed medical record review on 01/14/2015 revealed Patient #9 presented to the hospital's ED on 11/01/2013 at 1106 via private transportation accompanied by group home staff. Review revealed the patient's chief complaint (cc) was Crisis Evaluation Referral. Review of triage nurse documentation at 1116 revealed "pt admitted to new group home Monday, staff reports pt made threats to 'kill himself and everybody else.' Stated pt attempted to run away." Review of initial nursing assessment documentation revealed the patient was alert, awake, responsive to voice, oriented to person, time, and place. Review of a ED risk screen revealed the patient was assessed as "No" for risk for self harm/elopement. Review revealed the patient was evaluated by a ED physician at 1109. Review revealed a chief complaint of suicidal thoughts, expressing SI (suicidal ideation) and HI (homicidal ideation). Review revealed a past medical history of bipolar disorder, schizophrenia, and moderate mental retardation (MR). Review revealed the patient was assessed as no acute distress; awake and alert; oriented X4 (person, place, time, and situation); mood and affect normal. Extremities non-tender and no signs of injury. Review of a Affidavit and Petition For Involuntary Commitment form dated 11/01/2013 (note timed) revealed the Respondent was Patient #9 and the Petitioner was ED Physician A. Review revealed "The facts upon which this opinion is based are as follows....Patient is mentally challenged with history of Bipolar D/O (disorder) and Schizophrenia who is very unstable at this time. He is making threats that he will kill others at the group home and himself." Review of a "Findings and Custody Order Involuntary Commitment" revealed the order was signed on 11/01/2013 at 1258 by a Magistrate. Review revealed "The Court finds from the petition in the above matter that there are reasonable grounds to believe that the facts alleged in the petition are true and that the respondent (Patient #9) is probably: [X] 1. mentally ill and dangerous to self or others...." Review revealed the respondent was taken into custody by ABC City Police Officer on 11/01/2013 at 1336 (Patient in ED when taken into custody). Review of a Computerized Physician's Order Entry (CPOE) report, Order # 26, CPOE # 2, revealed a physician's order entered by ED Physician A on 11/01/2013 at 1358 for "Restraints, Place in", Frequency: "ONCE", Priority: "Routine". Review of nursing documentation revealed on 11/01/2013 at 1106 "Pt cc HI. Pt @ (at) group home. MR high functioning w (with)/Psychosis + (and) Bipolar. Pt pretending to shoot staff + 'flipping off' other patients from room." At 1245, "Pt moved to isolation room, IVC in place, officer @ bedside. Pt acting iriatic [sic], cuffed (restraint) to bed, Pt had previously tried to hang self w/belt. Now threatening officer + trying to bite him, Pt trying to break free from cuffs, bed now broken, officer warning pt of violent behavior." At 1400, "Pt out of control, violent, calling everyone 'F**king Bi**hs.' Broke posey chest vest....threatening to kill officer. Pt sprayed w/pepper spray @ close range." At 1410, "Pt refusing flushing treatment. V/S (vital signs) WNL (within normal limits), resting in bed with eyes open, resp (respirations) nonlabored." Review of a Comprehensive Assessment Tool-Intake form dated 11/01/2013 at 1452 revealed "...presents to (Hospital A) - ED c (with) group staff. Staff from group home report clt (client) was trying to run away this am and threatened to kill self as well as staff. Upon admission clt was making a gun with his fingers and placing it to the head of staff, threatening to stab another staff c a plastic fork and being verbally abusive. ...Clt was restrained on admission c forensic restraints and required pepper spray p (after) refusing chemical restraint. ..." Review of nursing documentation revealed at 1600, "Pt starting to yell out again, HPD (ABC City Police Department) at bedside." At 1755, "Pt resp WNL..." Review of Crisis Assessment documentation by mobile crisis management staff for Patient #9 dated 11/01/2013 at 1800 revealed the reason for referral was physical aggression, property destruction, threats of physical aggression, running away, verbal aggression, hallucinations or delusions, homicidal and suicidal. Review revealed "Became aggressive at GH (group home). Threatened to stab + shoot self + others. Ran to neighbors. Upon entering ED he refused meds + put a belt around his neck. He had to be pepper sprayed + put in 4 point restraints. ..." Review of mental status examination revealed the patient was disheveled with poor hygiene, and in 4 point restraints. Review of nursing documentation revealed at 1900, "...Pt sleeping on bed in 4 point restraints. HPD c (with) patient." Record review failed to reveal documentation of a 1-hour face-to-face assessment of Patient #9, conducted by a qualified physician/LIP or trained RN within 1 hour (1246 to 1345) after implementation of restraint for violent or self-destructive behaviors on 11/01/2013 at 1245 and within 1 hour (1401-1500) after being sprayed with pepper spray (a weapon) while restrained at 1400; that included the patient's immediate situation; the patient's reaction to the intervention; the patient's medical and behavioral condition; and the need to continue or terminate the restraint or seclusion per hospital policy.

Interview on 01/15/2015 at 1235 with the ED Nursing Director revealed patients brought into the ED under IVC or who are placed under IVC while in the ED were placed into "forensic" restraints (handcuffs or shackles) by the law enforcement officers. Interview revealed the ED staff did not view the placement of IVC patients in handcuffs or shackles as a restraint, because they were in the custody of law enforcement. Interview revealed there would not be any documentation of a face-to-face within 1-hour after initiation of restraint for Patient #9 because the handcuffs and shackles were not considered a restrictive intervention by ED staff. Interview confirmed the documentation of the CPOE order for restraint entered by ED Physician A on 11/01/2013 at 1358. Interview confirmed the ED staff did not follow the hospital's Restraint of Patient policy.
VIOLATION: QAPI Tag No: A0263
Based on restraint list/log documentation reviews, observations during tours, and staff interviews the hospital failed to maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement (QAPI) program for monitoring restraint in the ED.

The findings include:

1. The hospital failed to have the Quality Assessment Performance Improvement (QAPI) program monitoring the effectiveness and safety of involuntary commitment (IVC) patients restrained by Law Enforcement Officers in the ED.

~Cross refer to 482.21 (b) Quality Assessment Performance Improvement, Standard Tag A0273.