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.

IREDELL MEMORIAL HOSPITAL INC 557 BROOKDALE DR P O BOX 1828 STATESVILLE, NC 28677 Feb. 23, 2012
VIOLATION: GOVERNING BODY Tag No: A0043
Based on facility policy and procedure reviews, documentation reviews, medical record reviews, observations during tour, and staff interviews, the facility failed to have an effective Governing Body to ensure: the promotion of patient's rights; ensure an effective data-driven QAPI program; ensure nursing supervision in a manner to ensure the health and safety of patients.

The finding include:

1. The facility staff failed to protect and promote patient's rights for a safe environment as evidenced by failing to implement restraints in accordance with safe and appropriate restraint techniques; by qualified staff; and using approved restraint devices in order to prevent a patient injury.

~cross refer to 482.13 Patients' Rights - Condition Tag A0115.

2. The facility failed to maintain an effective data-driven QAPI program.

~cross refer to 482.21 QAPI, Condition Tag A0263.

3. The facility failed to have an effective nursing service providing oversight and supervision of day to day operations by failing to ensure nursing staff performed ongoing patient assessments for patients in restraints; supervised the testing of emergency equipment; ensured medications were administered as ordered by a physician; and ensured verbal orders were transcribed and authenticated per policy.

~cross refer to 482.23 Nursing Services, Condition Tag A0385.
VIOLATION: PATIENT RIGHTS Tag No: A0115
Based on facility policy and procedure reviews, medical record reviews, documentation reviews, restraint education training material reviews, personnel file reviews, and staff interviews, the facility staff failed to protect and promote patient's rights for a safe environment as evidenced by failing to implement restraints in accordance with safe and appropriate techniques; by qualified staff; and using approved restraint devices in order to prevent a patient injury.

The findings include:

1. The facility failed to ensure policies and procedures were reviewed and approved by the governing body to provide expectations of facility security personnel involved in patient care.

~cross refer to 482.13(c)(2) Patients' Rights - Care in a Safe Setting - Standard Tag A0144.

2. The facility staff failed to ensure use of metal ankle shackles (Forensic Restraints), applied by hospital security for 13 consecutive days and resulting in skin breakdown on day 7, were restricted for use only with a patient who was a prisoner or under arrest by law enforcement related to criminal activity for 1 of 1 records sampled of patient's placed in metal ankle shackles (Patient #2).

~cross refer to 482.13(e) Patients' Rights - Use of Restraint or Seclusion - Standard Tag A0154.

3. The facility staff failed to ensure restraints were discontinued at the earliest possible time for one of three patients restrained and for two of two episodes for the one patient (Patient #2).

~cross refer to 482.13(e)(9) Patients' Rights - Restraint or Seclusion - Standard Tag A0174.

4. The facility staff failed to ensure alternatives or other less restrictive interventions were attempted prior to a renewal order for one of three restraint records sampled (Patient #2).

~cross refer to 482.13(e)(16)(iii) Patients' Rights - Restraint or Seclusion - Standard Tag A0186.

5. The facility failed to provide seclusion training as a part of the facility's competency program for staff involved in the implementation of restraint or seclusion.

~cross refer to 482.13(f) Patients' Rights - Restraint or Seclusion - Standard Tag A0194.

6. The facility failed to ensure staff applying and monitoring restraints were trained and demonstrated competency in the application, monitoring and care of a patient in restraints for 5 of 5 personnel files reviewed of hospital security staff who utilize restraints.

~cross refer to 482.13(f)(1) Patients' Rights - Restraint or Seclusion - Standard Tag A0196.

7. The facility failed to ensure security staff utilizing restraints were trained in first aid techniques and certified in cardiopulmonary resuscitation for 5 of 5 personnel files reviewed for security staff.

~cross refer to 482.13(f)(2)(vii) Patients' Rights - Standard Tag A0206.

8. The facility staff failed to ensure the report to the Centers for Medicare and Medicaid Services (CMS) of the death of a patient that occurred while restrained and/or within 24 hours after being removed from restraints, was documented in the medical record for 2 of 4 sampled patient deaths reported to CMS (Patient #14, #15).

~cross refer to 482.13(g) Patients' Rights - Standard Tag A0214.
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on review of facility policies and procedures, medical record reviews and staff interviews, the facility failed to ensure policies and procedures were reviewed and approved by the governing body to provide expectations of facility security personnel involved in patient care to ensure the delivery of safe care.

The findings include:

Review on 02/23/2012 of facility policy "Patient Rights and Responsibilities" dated 01/2010 revealed "Patient Rights - We support the right of each patient:...To receive considerate, respectful, kind and compassionate care, from competent personnel, in an environment that preserves dignity and contributes a positive self-image, avoids unnecessary physical and mental discomfort, and is free from all forms of abuse, neglect..." Further review revealed "Restraint - The patient has the right to be free from physical or chemical restraint that is not medically necessary, or that is used for the purpose of coercion, discipline, convenience or retaliation. Physical or chemical restraints will be used only when less restrictive interventions are ineffective."

Review on 02/23/2012 of facility policy "Use of Restraints" dated 04/2010 revealed "Policy...Restraints are limited to clinically justified situations and are not applied for staff convenience, coercion, discipline, or retaliation. Restraints may only be imposed to ensure the immediate physical safety of the patient, a staff member, or others and must be discontinued at the earliest possible time. Restraints may be used in response to emergency, dangerous behavior, or as an adjunct to planned care. The use of restraints is not based on previous history of restraint use or solely on a history of dangerous behavior...Justification for the restraint is clearly documented in the patient's medical record..." Further review revealed "I. Definitions - Forms of Restraint - A. Physical Restraint: The direct application of any manual method or physical or mechanical device, material, or equipment, with or without the patient's permission, that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely...C. Devices: A restraint does not include...forensic and correction restrictions used for security..."

Closed record review on 02/22/2012 of Patient #2 revealed a [AGE] year old who presented to the facility's Emergency Department (ED) on 01/11/2012 at 0948 ambulatory with his mother for a chief complaint of abnormal behavior, difficulty sleeping, confusion and hearing voices. Review of the form "Examination and Recommendation to Determine Necessity for Involuntary Commitment" revealed the patient was made an involuntary commitment (IVC) by the ED physician on 01/11/2012 at 1000 and deemed "mentally ill" and "dangerous to self". Review of the form revealed the physician did not indicate the patient was "dangerous to others". Further review revealed the IVC was renewed on 01/18/2012 at 0900 and the examining physician indicated the patient was "mentally ill" and "dangerous to self". Review of the form revealed the physician did not indicate the patient was "dangerous to others". Review of nursing documentation on 01/12/2012 at 2130 revealed "Pt (patient) family visiting, brought pt McDonalds. Pt has not (symbol for "increased") agitation...2240 - Pt trembling, attempting to pace room and fidget (symbol for "with") shackles. (Physician name) made aware. Ativan (anti-anxiety medication) 2mg (milligrams) po (oral)...2337 - Pt resting quietly in bed, calm and cooperative at this time. Trazadone (anti-psychotic medication) 50mg po given..." Review of nursing documentation on 01/14/2012 at 2105 revealed "...Shackles on ankles...". Review failed to reveal any documentation of violent behavior as justification for use of shackles as documented at 2105 on 01/14/2012. Review of nursing documentation on 01/18/2012 at 0950 revealed "...Pt's lt (left) ankle (symbol for "with") neosporin (antibiotic ointment) & bandaid (symbol for "after") pt rubbed leg shackles until an abrasion was apparent. Scrubs pulled through cuffs & taped to pad his ankles." Review failed to reveal any documentation of violent behavior as justification for use of shackles as documented at 0950 on 01/18/2012. Review of nursing documentation on 01/18/2012 at 2100 revealed "pt back in room from shower. front of legs at ankle inspected for breakdown. area is reddened. socks pulled up under cuffs...". Review of nursing documentation on 01/24/2012 at 1441 revealed "security officer reports that pt's shackles were removed this am...". Review revealed the patient was transferred from the facility's emergency department to an acute psychiatric hospital on [DATE].

Interview with the security director on 02/22/2012 at 1030 revealed all security staff at the hospital are paid by the hospital and are part-time or PRN (as needed) staff. Interview revealed all security staff at the hospital are primarily employed by the local police department or local sheriff's office and work at the hospital as secondary employment. Interview revealed hospital security was called to observe Patient #2 for safety the day the patient (MDS) dated [DATE] because of his history of being unpredictable. Interview revealed Patient #2 was placed in shackles "sometime on his first day" as a patient in the emergency department. Interview revealed Patient #2 was placed in the metal ankle shackles because the patient attempted to elope from the emergency department on a prior visit in December 2011. Interview revealed since the patient was under an involuntary commitment (IVC) order, the security officers had to do whatever was necessary to maintain the patient's safety while in their custody (related to the IVC order) until the patient was at the psychiatric hospital. Interview revealed the patient remained in shackles until the day before he was discharged and transferred to the acute psychiatric hospital. Interview revealed the patient was in the metal ankle shackles, except for when he showered daily, from 01/11/2012 until 01/24/2012 (13 days). Interview revealed the metal ankle shackles remained on the patient since he was exhibiting behaviors which could possibly lead to violent outbursts. Interview revealed the patient was "shadow boxing, flashing gang signs and making sexual remarks to staff." Interview failed to reveal any violent or self-mutilating behaviors justifying the use or continued use of the metal ankle shackles. Interview revealed the security officers are responsible for application, monitoring and removal of the metal ankle shackles. Interview revealed no physician's order is required, "use of the shackles is at the discretion of the officer." Interview revealed there is no documentation available to know which officer applied the metal ankle shackles on Patient #2. Interview revealed there is no documented evidence Patient #2 was monitored while in the metal ankle shackles. Interview revealed the director was aware there was some skin irritation from the metal ankle shackles - "I couldn't tell you when, I just know he (Patient #2) was very active while in the shackles and that probably caused the irritation." Interview revealed "We follow our (law enforcement) department's policies for procedures." Interview revealed the hospital had not established any policies and procedures regarding use of metal handcuffs and ankle shackles. Interview revealed "Our (law enforcement) departmental policies would override any other policy (hospital policy)." Interview revealed the security officers, although being paid by the hospital, would always follow their primary employer's policies before any hospital-established policies related to procedures, such as use of force or use of metal handcuffs and ankle shackles.

Interview with administrative staff over the security department on 02/23/2012 at 1455 revealed all of the security officers are paid employees with PRN (as needed) status. Interview revealed there is no contract between the hospital and the local police department or sheriff's office. Interview revealed the hospital has some policies related to security, but no policies related to use of force or metal handcuffs and ankle shackles. Interview revealed the security officers have historically acted in their role as a police officer or sheriff's deputy in carrying out their responsibilities as hospital security. Interview revealed in carrying out their duties related to law enforcement in the hospital, the hospital-paid security officers have been following procedures established by their primary employer, either the local police department or sheriff's office. Interview revealed "we (hospital leadership) have not reviewed the policies" from the police department or sheriff's office. Interview failed to reveal any documented evidence the hospital's leadership had reviewed and approved any policies and procedures related to use of weapons, force and metal handcuffs/ankle shackles on patient's while working for the hospital as security officers.
VIOLATION: USE OF RESTRAINT OR SECLUSION Tag No: A0154
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on review of facility policies and procedures, medical records and staff interviews the facility staff failed to ensure use of metal ankle shackles (Forensic Restraints), applied by hospital security for 13 consecutive days and resulting in skin breakdown on day 7, were restricted for use only with a patient who was a prisoner or under arrest by law enforcement related to criminal activity for 1 of 1 records sampled of patient's placed in metal ankle shackles (Patient #2).

The findings include:

Review on 02/23/2012 of facility policy "Patient Rights and Responsibilities" dated 01/2010 revealed "Patient Rights - We support the right of each patient:...To receive considerate, respectful, kind and compassionate care, from competent personnel, in an environment that preserves dignity and contributes a positive self-image, avoids unnecessary physical and mental discomfort, and is free from all forms of abuse, neglect..." Further review revealed "Restraint - The patient has the right to be free from physical or chemical restraint that is not medically necessary, or that is used for the purpose of coercion, discipline, convenience or retaliation. Physical or chemical restraints will be used only when less restrictive interventions are ineffective."

Review on 02/23/2012 of facility policy "Use of Restraints" dated 04/2010 revealed "Policy...Restraints are limited to clinically justified situations and are not applied for staff convenience, coercion, discipline, or retaliation. Restraints may only be imposed to ensure the immediate physical safety of the patient, a staff member, or others and must be discontinued at the earliest possible time. Restraints may be used in response to emergency, dangerous behavior, or as an adjunct to planned care. The use of restraints is not based on previous history of restraint use or solely on a history of dangerous behavior...Justification for the restraint is clearly documented in the patient's medical record..." Further review revealed "I. Definitions - Forms of Restraint - A. Physical Restraint: The direct application of any manual method or physical or mechanical device, material, or equipment, with or without the patient's permission, that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely...C. Devices: A restraint does not include...forensic and correction restrictions used for security..."

Closed record review on 02/22/2012 of Patient #2 revealed a [AGE] year old who presented to the facility's Emergency Department (ED) 01/11/2012 at 0948 ambulatory with his mother for a chief complaint of abnormal behavior, difficulty sleeping, confusion and hearing voices. Review of the form "Examination and Recommendation to Determine Necessity for Involuntary Commitment" revealed the patient was made an involuntary commitment (IVC) by the ED physician on 01/11/2012 at 1000 and deemed "mentally ill" and "dangerous to self". Review of the form revealed the physician did not indicate the patient was "dangerous to others". Review of the IVC custody order revealed the order was received and served by a hospital security officer on 01/11/2012 at 1450. Further review revealed "Note to any law enforcement officer: You shall take the respondent into custody within 24 hours after the date this Order is signed. Without unnecessary delay after assuming custody, you shall take the respondent to an area facility for examination by a person authorized by law to conduct the examination...if an area facility is not available, you may detain the respondent under appropriate supervision, in the respondent's home, in a private hospital or clinic, or in a general hospital, but not in jail or other penal facility." Further review revealed the IVC was renewed on 01/18/2012 at 0900 and the examining physician indicated the patient was "mentally ill" and "dangerous to self". Review of the form revealed the physician did not indicate the patient was "dangerous to others". Review of the IVC custody order revealed the order was received and served by a hospital security officer on 01/18/2012 at 1128. Further review revealed "Note to any law enforcement officer: You shall take the respondent into custody within 24 hours after the date this Order is signed. Without unnecessary delay after assuming custody, you shall take the respondent to an area facility for examination by a person authorized by law to conduct the examination...if an area facility is not available, you may detain the respondent under appropriate supervision, in the respondent's home, in a private hospital or clinic, or in a general hospital, but not in jail or other penal facility." Review of nursing documentation on 01/12/2012 at 2130 revealed "Pt (patient) family visiting, brought pt McDonalds. Pt has not (symbol for "increased") agitation...2240 - Pt trembling, attempting to pace room and fidget (symbol for "with") shackles. (Physician name) made aware. Ativan (anti-anxiety medication) 2mg (milligrams) po (oral)...2337 - Pt resting quietly in bed, calm and cooperative at this time. Trazadone (anti-psychotic medication) 50mg po given..." Review of nursing documentation on 01/14/2012 at 2105 revealed "...Shackles on ankles...". Review failed to reveal any documentation of violent behavior as justification for use of shackles as documented at 2105 on 01/14/2012. Review of nursing documentation on 01/18/2012 at 0950 revealed "...Pt's lt (left) ankle (symbol for "with") neosporin (antibiotic ointment) & bandaid (symbol for "after") pt rubbed leg shackles until an abrasion was apparent. Scrubs pulled through cuffs & taped to pad his ankles." Review failed to reveal any documentation of violent behavior as justification for use of shackles as documented at 0950 on 01/18/2012. Review of nursing documentation on 01/18/2012 at 2100 revealed "pt back in room from shower. front of legs at ankle inspected for breakdown. area is reddened. socks pulled up under cuffs...". Review of nursing documentation on 01/24/2012 at 1441 revealed "security officer reports that pt's shackles were removed this am...". Review revealed the patient was transferred from the facility's emergency department to an acute psychiatric hospital on [DATE].

Interview on 02/23/2012 at 1500 with a hospital security officer (SO) revealed the SO is PRN or as needed at the hospital, and the hospital is the SO's secondary employment. Interview revealed the SO has primary employment with the local sheriff's department. Interview revealed the SO was called in to observe Patient #2 on 01/11/2012 and began his shift at 2115. Interview revealed the SO went into the emergency department to speak with the SO currently observing Patient #2. Interview revealed after a report, the SO went back to the security desk outside the emergency department to get the metal ankle shackles for Patient #2. Interview revealed "I went back to the emergency department and asked Patient #2 to sit on the bed while I put the metal ankle shackles on" and interview revealed the patient complied and was cooperative while the metal ankle shackles were applied. Interview revealed the SO applied the metal ankle shackles related to an attempted elopement by Patient #2 during an emergency department visit in December 2011, when the patient was under an involuntary commitment (IVC) order awaiting transfer to an acute psychiatric hospital. Interview revealed the patient was also "shadow-boxing, exercising, making sexual remarks to female staff and masturbating in the room." Interview revealed "since the patient was in my custody, and I didn't know much about him, I felt it was the best thing to do." Interview revealed the metal ankle shackles were applied between 2145 and 2200 on 01/11/2012. Interview revealed the patient was not under arrest and was not an incarcerated prisoner. Interview revealed the patient was under temporary policy custody for psychiatric evaluation and care related to the IVC order. Interview revealed after the metal ankle shackles were applied, the patient ate his meal, received some oral medications and slept until approximately 0600, with the metal ankle shackles still applied.

Interview with the security director on 02/22/2012 at 1030 revealed all security staff at the hospital are paid by the hospital and are part-time or PRN (as needed) staff. Interview revealed all security staff at the hospital are primarily employed by the local police department or local sheriff's office and work at the hospital as secondary employment. Interview revealed hospital security was called to observe Patient #2 for safety the day the patient (MDS) dated [DATE] because of his history of being unpredictable. Interview revealed Patient #2 was placed in shackles "sometime on his first day" as a patient in the emergency department. Interview revealed Patient #2 was placed in the metal ankle shackles because the patient attempted to elope from the emergency department on a prior visit in December 2012. Interview revealed since the patient was under an IVC order, the security officers had to do whatever was necessary to maintain the patient's safety while in their custody (related to the IVC order) until the patient was at the psychiatric hospital. Interview revealed the patient was not under arrest and was not an incarcerated prisoner. Interview revealed the patient remained in shackles until the day before he was discharged and transferred to the acute psychiatric hospital. Interview revealed the patient was in the metal ankle shackles, except for when he showered daily, from 01/11/2012 until 01/24/2012 (13 days). Interview revealed the metal ankle shackles remained on the patient since he was exhibiting behaviors which could possibly lead to violent outbursts. Interview revealed the patient was "shadow boxing, flashing gang signs and making sexual remarks to staff." Interview failed to reveal any violent or self-mutilating behaviors justifying the use or continued use of the metal ankle shackles as a restraint device, unapproved for use with hospital patients. Interview revealed the security officers are responsible for application, monitoring and removal of the metal ankle shackles. Interview revealed no physician's order is required, "use of the shackles is at the discretion of the officer." Interview revealed there is no documentation available to know which officer applied the metal ankle shackles on Patient #2. Interview revealed there is no documented evidence Patient #2 was monitored while in the metal ankle shackles for 13 days. Interview revealed the director was aware there was some skin irritation from the metal ankle shackles - "I couldn't tell you when, I just know he (Patient #2) was very active while in the shackles and that probably caused the irritation." Interview revealed "We follow our (law enforcement) department's policies for procedures." Interview revealed the hospital had not established any policies and procedures regarding use of metal handcuffs and ankle shackles. Interview revealed "Our (law enforcement) departmental policies would override any other policy (hospital policy)." Interview revealed the security officers, although being paid by the hospital, would always follow their primary employer's policies before any hospital-established policies related to procedures, such as use of force or use of metal handcuffs and ankle shackles. Interview failed to reveal any policies or procedures restricting the use of force or use of metal handcuffs and ankle shackles on hospital patients who were not under arrest for criminal activity or an incarcerated prisoner.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0174
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on review of facility policies and procedures, medical records and staff interviews, the facility staff failed to ensure restraints were discontinued at the earliest possible time for one of three patients restrained and for two of two episodes for the one patient (Patient #2).

The findings include:

Review on 02/23/2012 of facility policy "Patient Rights and Responsibilities" dated 01/2010 revealed "Patient Rights - We support the right of each patient:...To receive considerate, respectful, kind and compassionate care, from competent personnel, in an environment that preserves dignity and contributes a positive self-image, avoids unnecessary physical and mental discomfort, and is free from all forms of abuse, neglect..." Further review revealed "Restraint - The patient has the right to be free from physical or chemical restraint that is not medically necessary, or that is used for the purpose of coercion, discipline, convenience or retaliation."

Review on 02/23/2012 of facility policy "Use of Restraints" dated 04/2010 revealed "V. Indications for Violent or Self-Destructive Restraints...Restraints may be ordered and applied for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member or others and alternatives to physical interventions would not be effective...4. Additionally, patients in Violent or Self-Destructive restraints are assessed initially and every fifteen minutes times 4 and then every hour by an RN (registered nurse). At a minimum, assessment should include...Readiness for discontinuation...VI. Documentation - When a restraint is used, the following should be documented in the medical record...The patient's response to the intervention(s) used, including rationale for continued use..."

1. Closed record review on 02/23/2012 of Patient #2 revealed a [AGE] year old who presented to the facility's Emergency Department (ED) on 01/11/2012 at 0948 ambulatory with his mother for a chief complaint of abnormal behavior, difficulty sleeping, confusion and hearing voices. Review of the form "Examination and Recommendation to Determine Necessity for Involuntary Commitment" revealed the patient was made an involuntary commitment (IVC) by the ED physician on 01/11/2012 at 1000 and deemed "mentally ill" and "dangerous to self". Review of the form revealed the physician did not indicate the patient was "dangerous to others". Further review revealed the IVC was renewed on 01/18/2012 at 0900 and the examining physician indicated the patient was "mentally ill" and "dangerous to self". Review of the form revealed the physician did not indicate the patient was "dangerous to others". Review of nursing documentation on 01/12/2012 at 2130 revealed "Pt (patient) family visiting, brought pt McDonalds. Pt has not (symbol for "increased") agitation...2240 - Pt trembling, attempting to pace room and fidget (symbol for "with") shackles. (Physician name) made aware. Ativan (anti-anxiety medication) 2mg (milligrams) po (oral)...2337 - Pt resting quietly in bed, calm and cooperative at this time. Trazadone (anti-psychotic medication) 50mg po given..." Review of nursing documentation on 01/14/2012 at 2105 revealed "...Shackles on ankles...". Review failed to reveal any documentation of violent behavior as justification for use of shackles as documented at 2105 on 01/14/2012. Review of nursing documentation on 01/18/2012 at 0950 revealed "...Pt's lt (left) ankle (symbol for "with") neosporin (antibiotic ointment) & bandaid (symbol for "after") pt rubbed leg shackles until an abrasion was apparent. Scrubs pulled through cuffs & taped to pad his ankles." Review failed to reveal any documentation of violent behavior as justification for use of shackles as documented at 0950 on 01/18/2012. Review of nursing documentation on 01/18/2012 at 2100 revealed "pt back in room from shower. front of legs at ankle inspected for breakdown. area is reddened. socks pulled up under cuffs...". Review of nursing documentation on 01/24/2012 at 1441 revealed "security officer reports that pt's shackles were removed this am...". Review revealed the patient was transferred from the facility's emergency department to an acute psychiatric hospital on [DATE].

Interview on 02/23/2012 at 1500 with a hospital security officer (SO) revealed the SO is PRN or as needed at the hospital, and the hospital is the SO's secondary employment. Interview revealed the SO has primary employment with the local sheriff's department. Interview revealed the SO was called in to observe Patient #2 on 01/11/2012 and began his shift at 2115. Interview revealed the SO went into the emergency department to speak with the SO currently observing Patient #2. Interview revealed after a report, the SO went back to the security desk outside the emergency department to get the metal ankle shackles for Patient #2. Interview revealed "I went back to the emergency department and asked Patient #2 to sit on the bed while I put the metal ankle shackles on" and interview revealed the patient complied and was cooperative while the metal ankle shackles were applied. Interview revealed the SO applied the metal ankle shackles related to an attempted elopement by Patient #2 during an emergency department visit in December 2011, when the patient was under an involuntary commitment (IVC) order awaiting transfer to an acute psychiatric hospital. Interview revealed the patient was also "shadow-boxing, exercising, making sexual remarks to female staff and masturbating in the room." Interview revealed "since the patient was in my custody, and I didn't know much about him, I felt it was the best thing to do." Interview revealed the metal ankle shackles were applied between 2145 and 2200 on 01/11/2012. Interview revealed the patient was not under arrest and was not an incarcerated prisoner. Interview revealed the patient was under temporary policy custody for psychiatric evaluation and care related to the IVC order. Interview revealed after the metal ankle shackles were applied, the patient ate his meal, received some oral medications and slept until approximately 0600, with the metal ankle shackles still applied.

Interview on 02/23/2012 at 1300 with an ED physician who documented on Patient #2s record on 01/18/2012 revealed the physician saw the patient on 01/18/2012 to reorder one of the patient's home medications. Interview when asked about Patient #2 being in the metal ankle shackles revealed "I had nothing to do with that (the metal ankle shackles)." Interview revealed "I had minimal interaction with him (Patient #2)." Interview failed to reveal any justification for the continuance of the metal ankle shackles used as a restraint device on Patient #2.

Interview on 02/22/2012 at 1735 with a staff RN in the ED revealed the RN was the primary nurse assigned to care for Patient #2 for many of her shifts during the patient's stay from 01/11/2012 through 01/25/2012. Interview revealed the patient was in the metal ankle shackles every shift she was there "security would remove the shackles for him (Patient #2) to shower, and then put them back on...they (security) were responsible for the shackles." Interview when asked about Patient #2 being in the metal ankle shackles revealed "It made the security officer's job easier...from what I understand, he (Patient #2) was a flight risk." Interview revealed "He (Patient #2) made me nervous...he looked very unstable and wouldn't sit still...he was a thin build about five foot six inches (height) and had tattoos all over his body." Interview failed to reveal any episodes of violent or self-destructive behavior exhibited by Patient #2 during the RN's shifts as his primary RN. Interview revealed the RN knew of no staff request made of security to have the metal ankle shackles removed. Interview failed to reveal any documented evidence why Patient #2 remained in the metal ankle shackles for 13 days.

2. Closed record review on 02/23/2012 of Patient #2 revealed a [AGE] year old (date of birth 01/11/1996) who presented to the facility's ED 12/14/2011 at 0404 ambulatory with his family for a chief complaint of "talking out of head...released by Charlotte police (symbol for "secondary to") talking crazy". Review of nursing triage documentation revealed "brought by two cousins - driving truck in hi speed chase (symbol for "with" H.P. in Charlotte." Review of the form "Examination and Recommendation to Determine Necessity for Involuntary Commitment" revealed the patient was made an involuntary commitment (IVC) by the ED physician on 12/14/2011 at 0500 and deemed "mentally ill". Review of the form revealed the physician did not indicate the patient was "dangerous to others" or "dangerous to self". Documentation revealed "(Patient's name) was brought in by family very concerned about patient. For past 2 weeks patient has been displaying psychotic behavior. Talking about death & taking orders from devils, demons & vampires. Patient not sleeping & says he has to stay up @ night to work for the devil. He is having auditory & visual hallucinations, was involved in high speed chase from police 2 days ago. Family fears he is a danger to himself and others." Review of nursing documentation 12/15/2011 at 1000 revealed "Pt requested to use phone, standing (symbol for "with") police officer (hospital security officer) & CNA (certified nursing assistant), threw phone to ground, ran down hallway (symbol for "with") police in chase. Returned to room unharmed, restrained, continues to request phone. Advised no phone @ this time. Medicated as ordered. Lying bed speaking (symbol for "with") CNA...1100...Sleeping...police restraint removed, hospital restraints remain in place...1200 - restraint protocol followed...1300 - eating lunch, one wrist restraint removed...calm...1400 - sleeping...1 leg restraint removed...1450 - sleeping 3 pt ("point" or restraint on three extremities) restraint...1600 - restraints removed by Dr. (name of physician)...1730...Pt watching TV quietly...1800 - Pt finished eating supper (symbol for "without") problem...2050 - Family to see pt. Pt unagitated...2215 - Pt still calmly visiting (symbol for "with") family...2245 - Pt still tolerating restraint (symbol for "without") increased agitation...2330 - Pt sitting up on end of bed...Pt holding onto end of bed...2340 - Pt standing up @ door...0053 - Pt awake. Restraints remain on one foot...0056 - Restraint D/C'd (discontinued)" Further review of nursing documentation on 12/16/2011 at 0226 revealed "Per Dr. (name of physician), restraints not medically necessary (symbol for "secondary") to pt not displaying threatening behavior. Pt up pacing in room. Pt doing pushups on floor..." Review of nursing documentation on 12/16/2011 at 0700 revealed "...Pt resting bed. Sitter & officer @ bedside...0745 - Dr. (name of physician) asked if restraints could be restarted. Dr. (name of physician) declined restraint order...0830 - Pt to bathroom...Pt appears cooperating...". Further review of documentation on 12/16/2012 at 0900 revealed "pts breakfast arrives, pt somewhat less restless...(hospital security officer) placed legs in cuffs on pt..." Review of physician restraint orders revealed restraints were ordered on [DATE] at 0955 with a physician's order to renew restraints at 1155, 1355, 1555, 1755, 1955, and 2155. Review of the "Violent or Self Destructive Restraint Care Flow Sheet" revealed the patient was in restraints from 0955 on 12/15/2011 until 0055 on 12/16/2011. Further review of the row "Restraint still indicated for Behavior Management Reasons" on the restraint flow sheet failed to reveal a behavior code, as indicated on the flow sheet, to justify continuance of the restraints. Review revealed the patient was transferred to an acute psychiatric hospital 12/16/2011 at 1350.

Interview on 02/23/2012 at 1600 with the ED manager revealed patients should only be restrained in order to ensure the immediate safety of the patient and staff and should be discontinued at the earliest possible time. Interview revealed during the 12/14/2011 visit, the patient attempted to elope, however, was "tackled" in the ED parking lot and had to be "dragged back into the ED" and was placed in metal handcuffs by the hospital security officer. Interview revealed all hospital security officers are sworn police officers or sheriff's deputies. Interview revealed the documentation revealed the patient was in the metal handcuffs and four point hospital restraints for one hour until the metal handcuffs were removed. Interview revealed the patient was in the hospital restraints from 0955 on 12/15/2011 until 0055 on 12/16/2011 (15 hours in restraints). Interview revealed the documentation failed to reveal evidence how many extremities were restrained during each monitoring cycle (at least every one hour). Interview revealed documentation failed to reveal justification for initiation and continuance of restraint for 15 continuous hours beginning 12/15/2011 at 0955. Review of documentation failed to reveal a justification for the patient's leg to be cuffed. Further interview failed to reveal justification for restraining the patient in metal ankle shackles for 13 days beginning 01/11/2012 at approximately 2145. Interview revealed staff failed to follow facility policy regarding a patient's right to be free of restraint by failing to ensure restraint was discontinued at the earliest possible time on 12/15/2011 and on 01/11/2012.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0186
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on review of facility policies and procedures, medical records and staff interviews the facility staff failed to ensure alternatives or other less restrictive interventions were attempted prior to a renewal order for one of three restraint records sampled (Patient #2).

The findings included:

Review on 02/23/2012 of facility policy "Patient Rights and Responsibilities" dated 01/2010 revealed "Patient Rights - We support the right of each patient:...To receive considerate, respectful, kind and compassionate care, from competent personnel, in an environment that preserves dignity and contributes a positive self-image, avoids unnecessary physical and mental discomfort, and is free from all forms of abuse, neglect..." Further review revealed "Restraint - The patient has the right to be free from physical or chemical restraint that is not medically necessary, or that is used for the purpose of coercion, discipline, convenience or retaliation."

Review on 02/23/2012 of facility policy "Use of Restraints" dated 04/2010 revealed "V. Indications for Violent or Self-Destructive Restraints...Restraints may be ordered and applied for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member or others and alternatives to physical interventions would not be effective...4. Additionally, patients in Violent or Self-Destructive restraints are assessed initially and every fifteen minutes times 4 and then every hour by an RN (registered nurse). At a minimum, assessment should include...Readiness for discontinuation...VI. Documentation - When a restraint is used, the following should be documented in the medical record...Alternatives or other less restrictive interventions attempted..."

Closed record review on 02/23/2012 of Patient #2 revealed a [AGE] year old (date of birth 01/11/1996) who presented to the facility's ED 12/14/2011 at 0404 ambulatory with his family for a chief complaint of "talking out of head...released by Charlotte police (symbol for "secondary to") talking crazy". Review of nursing triage documentation revealed "brought by two cousins - driving truck in hi speed chase (symbol for "with" H.P. in Charlotte." Review of the form "Examination and Recommendation to Determine Necessity for Involuntary Commitment" revealed the patient was made an involuntary commitment (IVC) by the ED physician on 12/14/2011 at 0500 and deemed "mentally ill". Review of the form revealed the physician did not indicate the patient was "dangerous to others" or "dangerous to self". Documentation revealed "(Patient's name) was brought in by family very concerned about patient. For past 2 weeks patient has been displaying psychotic behavior. Talking about death & taking orders from devils, demons & vampires. Patient not sleeping & says he has to stay up @ night to work for the devil..He is having auditory & visual hallucinations, was involved in high speed chase from police 2 days ago. Family fears he is a danger to himself and others." Review of nursing documentation 12/15/2011 at 1000 revealed "Pt requested to use phone, standing (symbol for "with") police officer (hospital security officer) & CNA (certified nursing assistant), threw phone to ground, ran down hallway (symbol for "with") police in chase. Returned to room unharmed, restrained, continues to request phone. Advised no phone @ this time. Medicated as ordered. Lying bed speaking (symbol for "with") CNA...1100...Sleeping...police restraint removed, hospital restraints remain in place...1200 - restraint protocol followed...1300 - eating lunch, one wrist restraint removed...calm...1400 - sleeping...1 leg restraint removed...1450 - sleeping 3 pt ("point" or restraint on three extremities) restraint...1600 - restraints removed by Dr. (name of physician)...1730...Pt watching TV quietly...1800 - Pt finished eating supper (symbol for "without") problem...2050 - Family to see pt. Pt unagitated...2215 - Pt still calmly visiting (symbol for "with") family...2245 - Pt still tolerating restraint (symbol for "without") increased agitation...2330 - Pt sitting up on end of bed...Pt holding onto end of bed...2340 - Pt standing up @ door...0053 - Pt awake. Restraints remain on one foot...0056 - Restraint D/C'd (discontinued)" Further review of nursing documentation on 12/16/2011 at 0226 revealed "Per Dr. (name of physician), restraints not medically necessary (symbol for "secondary" to pt not displaying threatening behavior. Pt up pacing in room. Pt doing pushups on floor..." Review of nursing documentation on 12/16/2011 at 0700 revealed "...Pt resting bed. Sitter & officer @ bedside...0745 - Dr. (name of physician) asked if restraints could be restarted. Dr. (name of physician) declined restraint order...0830 - Pt to bathroom...Pt appears cooperating...". Further review of documentation on 12/16/2012 at 0900 revealed "pts breakfast arrives, pt somewhat less restless...(hospital security officer) placed legs in cuffs on pt..." Review of physician restraint orders revealed restraints were ordered on [DATE] at 0955 with a physician's order to renew restraints at 1155, 1355, 1555, 1755, 1955, and 2155. Review of physician renewal orders failed to reveal any alternatives attempted prior to the renewal of the restraint orders from 0955 through 2155. Review of the "Violent or Self Destructive Restraint Care Flow Sheet" revealed the patient was in restraints from 0955 on 12/15/2011 until 0055 on 12/16/2011. Review of the restraint monitoring flow sheet failed to reveal any alternatives attempted during the monitoring cycle (at least every one hour). Record review failed to reveal any ongoing documented evidence of alternatives attempted prior to renewal of restraints lasting 15 hours. Review revealed the patient was transferred to an acute psychiatric hospital 12/16/2011 at 1350.

Interview on 02/23/2012 at 1600 with the ED manager revealed patients should only be restrained in order to ensure the immediate safety of the patient and staff and alternatives to restraint should be documented prior to renewal of the order for violent and/or self-destructive behavior restraints. Interview revealed during the 12/14/2011 visit, the patient attempted to elope, however, was "tackled" in the ED parking lot and had to be "dragged back into the ED" and was placed in metal handcuffs by the hospital security officer. Interview revealed all hospital security officers are sworn police officers or sheriff's deputies. Interview revealed the documentation revealed the patient was in the metal handcuffs and four point hospital restraints for one hour until the metal handcuffs were removed. Interview revealed the patient was in the hospital restraints from 0955 on 12/15/2011 until 0055 on 12/16/2011 (15 hours in restraints). Interview revealed the documentation failed to reveal evidence how many extremities were restrained during each monitoring cycle (at least every one hour). Interview revealed documentation failed to reveal ongoing alternatives to restraint attempted prior to continuance of restraint for 15 continuous hours beginning 12/15/2011 at 0955. Interview revealed staff failed to follow facility policy regarding a patient's right to be free of restraint by failing to ensure alternatives to restraint were attempted prior to requesting a continuance order for restraint from 12/15/2011 through 12/16/2011.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0194
Based on facility policy review, restraint education training material review, annual competency/training file reviews, and staff interviews the facility failed to provide seclusion training as a part of the facility's competency program for staff involved in the implementation of restraint or seclusion.

The findings include:

Review on 02/23/2012 of the facility's current restraint training course outline "Education Standard For Use of Restraints" revised 04/14/2010, revealed no documented evidence seclusion was taught as a part of the restraint training program.

Review on 02/23/2012 of the facility's current annual "Housewide Competency Skills Addendum Checklist" revealed "For Staff in Patient Care Areas Who Restrain Patients." Further review revealed no documented evidence seclusion was a required competency check.

Review on 02/23/2012 of the facility's current (new hire) "Health Care Worker Orientation Tracking Checklist" revised 02/16/2006 revealed seclusion was not a topic covered during hospital orientation.

Review on 02/23/2012 of the annual competency/training files for Staff Nurses #1, #2, #3, #4, #5, #6 and Certified Nursing Assistants #1 and #2, revealed no documented evidence of seclusion training upon hire or thereafter.

Concurrent interviews on 02/23/2012 at 1337 with Hospital Educator #1, Quality Specialist #1 and ED Clinical Educator #1 revealed the three employees are restraint trainers for the hospital. Interview revealed the restraint trainers follow the "Education Standard For Use of Restraint" course outline. Interview revealed the course outline does not include seclusion. Interview revealed "We do not teach seclusion." Interview confirmed staff involved in the application and use of restrictive interventions are not trained on the use of seclusion.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0196
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on review of facility policies and procedures, personnel files and staff interviews, the facility failed to ensure staff applying and monitoring restraints were trained and demonstrated competency in the application, monitoring and care of a patient in restraints for 5 of 5 personnel files reviewed of hospital security staff who utilize restraints.

The findings include:

Review on 02/23/2012 of facility policy "Patient Rights and Responsibilities" dated 01/2010 revealed "Patient Rights - We support the right of each patient:...To receive considerate, respectful, kind and compassionate care, from competent personnel..."

Review on 02/23/2012 of facility policy "Use of Restraints" dated 04/2010 revealed "VII. Physician / Staff Training...Staff Training: Before applying restraints or monitoring a patient in restraints, hospital staff, as appropriate to their specific job duties, are trained and able to demonstrate competency in the application of restraints and monitoring, assessment and providing care for a patient in restraint. Training is provided through initial orientation and annual competencies. Training an successful demonstration of competency is documented in staff education records."

Closed record review on 02/23/2012 of Patient #2 revealed a [AGE] year old who presented to the facility's Emergency Department (ED) 01/11/2012 at 0948 ambulatory with his mother for a chief complaint of abnormal behavior, difficulty sleeping, confusion and hearing voices. Review of the form "Examination and Recommendation to Determine Necessity for Involuntary Commitment" revealed the patient was made an involuntary commitment (IVC) by the ED physician on 01/11/2012 at 1000 and deemed "mentally ill" and "dangerous to self". Review of the form revealed the physician did not indicate the patient was "dangerous to others". Further review revealed the IVC was renewed on 01/18/2012 at 0900 and the examining physician indicated the patient was "mentally ill" and "dangerous to self". Review of the form revealed the physician did not indicate the patient was "dangerous to others". Review of nursing documentation on 01/12/2012 at 2130 revealed "Pt (patient) family visiting, brought pt McDonalds. Pt has not (symbol for "increased") agitation...2240 - Pt trembling, attempting to pace room and fidget (symbol for "with") shackles. (Physician name) made aware. Ativan (anti-anxiety medication) 2mg (milligrams) po (oral)...2337 - Pt resting quietly in bed, calm and cooperative at this time. Trazadone (anti-psychotic medication) 50mg po given..." Review of nursing documentation on 01/14/2012 at 2105 revealed "...Shackles on ankles...". Review failed to reveal any documentation of violent behavior as justification for use of shackles as documented at 2105 on 01/14/2012. Review of nursing documentation on 01/18/2012 at 0950 revealed "...Pt's lt (left) ankle (symbol for "with") neosporin (antibiotic ointment) & bandaid (symbol for "after") pt rubbed leg shackles until an abrasion was apparent. Scrubs pulled through cuffs & taped to pad his ankles." Review failed to reveal any documentation of violent behavior as justification for use of shackles as documented at 0950 on 01/18/2012. Review of nursing documentation on 01/18/2012 at 2100 revealed "pt back in room from shower. front of legs at ankle inspected for breakdown. area is reddened. socks pulled up under cuffs...". Review of nursing documentation on 01/24/2012 at 1441 revealed "security officer reports that pt's shackles were removed this am...". Review revealed the patient was transferred from the facility's emergency department to an acute psychiatric hospital on [DATE].

Interview on 02/23/2012 at 1500 with a hospital security officer (SO) revealed the SO is PRN or as needed at the hospital, and the hospital is the SO's secondary employment. Interview revealed the SO has primary employment with the local sheriff's department. Interview revealed the SO was called in to observe Patient #2 on 01/11/2012 and began his shift at 2115. Interview revealed the SO went into the emergency department to speak with the SO currently observing Patient #2. Interview revealed after a report, the SO went back to the security desk outside the emergency department to get the metal ankle shackles for Patient #2. Interview revealed "I went back to the emergency department and asked Patient #2 to sit on the bed while I put the metal ankle shackles on" and interview revealed the patient complied and was cooperative while the metal ankle shackles were applied.

Review on 02/23/2012 of the personnel file for Staff #9, the hospital SO who applied the metal ankle shackles to Patient #2 on 01/11/2012, revealed the SO's date of hire to be 9/21/2009. Review failed to reveal any restraint or seclusion training during orientation or since hire.

Review on 02/23/2012 of personnel file for Staff #6 revealed the staff is a hospital SO with a hire date of 08/16/2010. Review of "Officer's Daily Worksheet" dated 01/12/2012 revealed the SO monitored Patient #2 while in the metal shackles being used as a restraint. Review failed to reveal any restraint or seclusion training during orientation or since hire.

Interview on 02/22/2012 at 1620 with Staff #7, a hospital SO revealed the SO sat with Patient #2 during his stay from 01/11/2012 through 01/25/2012. Interview revealed the SO monitored the patient while in the metal ankle shackles being used as a restraint.

Review on 02/23/2012 of personnel file for Staff #7 revealed the staff is a hospital SO with a hire date of 03/24/1995. Review failed to reveal any restraint or seclusion training during orientation or since hire.

Interview on 02/23/2012 at 1455 with administrative staff over the hospital's security department revealed the facility has not been requiring the SOs to go through the hospital's restraint training at orientation or on an annual basis.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0206
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on review of facility policies and procedures, personnel files and staff interviews the facility failed to ensure security staff utilizing restraints were trained in first aid techniques and certified in cardiopulmonary resuscitation for 5 of 5 personnel files reviewed for security staff.

The findings included:

Review on 02/23/2012 of facility policy "Patient Rights and Responsibilities" dated 01/2010 revealed "Patient Rights - We support the right of each patient:...To receive considerate, respectful, kind and compassionate care, from competent personnel..."

Review on 02/23/2012 of facility policy "Use of Restraints" dated 04/2010 revealed "VII. Physician / Staff Training...Staff Training: Before applying restraints or monitoring a patient in restraints, hospital staff, as appropriate to their specific job duties, are trained and able to demonstrate competency in the application of restraints and monitoring, assessment and providing care for a patient in restraint. Training is provided through initial orientation and annual competencies. Training an successful demonstration of competency is documented in staff education records. As appropriate to job duties, staff training will include...The use of first aid techniques and certification/re-certification in the use of cardiopulmonary resuscitation."

Closed record review on 02/23/2012 of Patient #2 revealed a [AGE] year old who presented to the facility's Emergency Department (ED) 01/11/2012 at 0948 ambulatory with his mother for a chief complaint of abnormal behavior, difficulty sleeping, confusion and hearing voices. Review of the form "Examination and Recommendation to Determine Necessity for Involuntary Commitment" revealed the patient was made an involuntary commitment (IVC) by the ED physician on 01/11/2012 at 1000 and deemed "mentally ill" and "dangerous to self". Review of the form revealed the physician did not indicate the patient was "dangerous to others". Further review revealed the IVC was renewed on 01/18/2012 at 0900 and the examining physician indicated the patient was "mentally ill" and "dangerous to self". Review of the form revealed the physician did not indicate the patient was "dangerous to others". Review of nursing documentation on 01/12/2012 at 2130 revealed "Pt (patient) family visiting, brought pt McDonalds. Pt has not (symbol for "increased") agitation...2240 - Pt trembling, attempting to pace room and fidget (symbol for "with") shackles. (Physician name) made aware. Ativan (anti-anxiety medication) 2mg (milligrams) po (oral)...2337 - Pt resting quietly in bed, calm and cooperative at this time. Trazadone (anti-psychotic medication) 50mg po given..." Review of nursing documentation on 01/14/2012 at 2105 revealed "...Shackles on ankles...". Review failed to reveal any documentation of violent behavior as justification for use of shackles as documented at 2105 on 01/14/2012. Review of nursing documentation on 01/18/2012 at 0950 revealed "...Pt's lt (left) ankle (symbol for "with") neosporin (antibiotic ointment) & bandaid (symbol for "after") pt rubbed leg shackles until an abrasion was apparent. Scrubs pulled through cuffs & taped to pad his ankles." Review failed to reveal any documentation of violent behavior as justification for use of shackles as documented at 0950 on 01/18/2012. Review of nursing documentation on 01/18/2012 at 2100 revealed "pt back in room from shower. front of legs at ankle inspected for breakdown. area is reddened. socks pulled up under cuffs...". Review of nursing documentation on 01/24/2012 at 1441 revealed "security officer reports that pt's shackles were removed this am...". Review revealed the patient was transferred from the facility's emergency department to an acute psychiatric hospital on [DATE].

Interview on 02/23/2012 at 1500 with a hospital security officer (SO) revealed the SO is PRN or as needed at the hospital, and the hospital is the SO's secondary employment. Interview revealed the SO has primary employment with the local sheriff's department. Interview revealed the SO was called in to observe Patient #2 on 01/11/2012 and began his shift at 2115. Interview revealed the SO went into the emergency department to speak with the SO currently observing Patient #2. Interview revealed after a report, the SO went back to the security desk outside the emergency department to get the metal ankle shackles for Patient #2. Interview revealed "I went back to the emergency department and asked Patient #2 to sit on the bed while I put the metal ankle shackles on" and interview revealed the patient complied and was cooperative while the metal ankle shackles were applied.

Review on 02/23/2012 of the personnel file for Staff #9, the hospital SO who applied the metal ankle shackles to Patient #2 on 01/11/2012, revealed the SO's date of hire to be 9/21/2009. Review failed to reveal any training in first aid techniques or in the use of cardiopulmonary resuscitation.

Review on 02/23/2012 of personnel file for Staff #6 revealed the staff is a hospital SO with a hire date of 08/16/2010. Review of "Officer's Daily Worksheet" dated 01/12/2012 revealed the SO monitored Patient #2 while in the metal shackles being used as a restraint. Review failed to reveal any training in first aid techniques or in the use of cardiopulmonary resuscitation.

Interview on 02/22/2012 at 1620 with Staff #7, a hospital SO revealed the SO sat with Patient #2 during his stay from 01/11/2012 through 01/25/2012. Interview revealed the SO monitored the patient while in the metal ankle shackles being used as a restraint.

Review on 02/23/2012 of personnel file for Staff #7 revealed the staff is a hospital SO with a hire date of 03/24/1995. Review failed to reveal any training in first aid techniques or in the use of cardiopulmonary resuscitation.

Job description review on 02/23/2012 for the hospital's "Security Officer" revealed no requirement for training in first aid techniques or in the use of cardiopulmonary resuscitation.

Interview on 02/23/2012 at 1455 with administrative staff over the hospital's security department revealed the facility has not requiring the SOs to provide documentation of Review failed to reveal any training in first aid techniques or in the use of cardiopulmonary resuscitation.
VIOLATION: PATIENT RIGHTS: SECLUSION OR RESTRAINT Tag No: A0214
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on facility policy review, Hospital Restraint/Seclusion Death Report Worksheet reviews, closed medical record reviews, and staff interview, the facility staff failed to ensure the report to the Centers for Medicare and Medicaid Services (CMS) of the death of a patient that occurred while restrained and/or within 24 hours after being removed from restraints, was documented in the medical record for 2 of 4 sampled patient deaths reported to CMS (#14, #15).

The findings include:

Review of current hospital policy "Use of Restraints" revised April 2010, revealed "...VIII. CONTINUOUS QUALITY IMPROVEMENT ...The individual making the report must document the date and time and 'Death reported to CMS' in the physician's progress notes. ..."

1. Review on 02/22/2012 at 1520 of a Hospital Restraint/Seclusion Death Report Worksheet for Patient #15, revealed a [AGE] year-old patient was admitted on [DATE] for abdominal pain. Review revealed the patient expired on [DATE] at 2020. Review revealed the patient died while in two point, soft wrist restraints. Review revealed the CMS Regional Office was notified of the death on 01/10/2012 at 1000.

Closed Medical Record review for Patient #15 on 02/22/2012 at 1520 failed to reveal any available documentation in the patient's medical record of the date and time the death was reported to CMS.

Interview on 02/23/2012 at 1333 with Quality Specialist #1 revealed she is responsible for reporting deaths in/or associated with restraints to CMS. Interview revealed once she is notified of a death she completes the Hospital Restraint/Seclusion Death Report Worksheet and faxes the document to CMS. Interview revealed afterwards she documents the notification to CMS on a progress note in the patient's medical record. Interview revealed "for what ever reason, I was distracted and did not get back to the chart to document the notification." Interview revealed she documented a late entry into Patient #15's medical record on 02/22/2012 at 1525 (44 days after CMS notification) after the omission was identified by the surveyor.

2. Review on 02/22/2012 at 1520 of a Hospital Restraint/Seclusion Death Report Worksheet for Patient #14, revealed a [AGE] year-old patient was admitted on [DATE] for chest pain. Review revealed the patient expired on [DATE] at 1402. Review revealed the patient died while in two point, soft wrist restraints. Review revealed the CMS Regional Office was notified of the death on 02/15/2012 at 1500.

Closed medical record review for Patient #14 on 02/22/2012 at 1520 failed to reveal any available documentation in the patient's medical record of the date and time the death was reported to CMS.

Interview on 02/23/2012 at 1333 with Quality Specialist #1 revealed she is responsible for reporting deaths in/or associated with restraints to CMS. Interview revealed once she is notified of a death she completes the Hospital Restraint/Seclusion Death Report Worksheet and faxes the document to CMS. Interview revealed afterwards she documents the notification to CMS on a progress note in the patient's medical record. Interview revealed "for what ever reason, I was distracted and did not get back to the chart to document the notification." Interview revealed she documented a late entry into Patient #14's medical record on 02/22/2012 (7 days after CMS notification) after the omission was identified by the surveyor.
VIOLATION: QAPI Tag No: A0263
Based on review of facility policy and procedures, medical record reviews, Quality Assessment and Performance Improvement (QAPI) data, incident logs, QAPI meeting minutes and staff interviews, the hospital failed to maintain an effective, data-driven QAPI program.

The findings include:

1. Facility staff failed to ensure adverse patient events were reported to the hospital's QAPI program for two of two incidents involving one of one records reviewed with incidents (#2).

~cross refer to 482.21(a)(2) QAPI Quality Indicators - Standard Tag A0267.


2. The hospital failed to monitor the effectiveness and safety of services by failing to ensure restraint education was effective in improving monitoring and reassessment of patients in restraint.

~ cross refer to 482.21(b)(2)(i) QAPI Quality of Care - Standard Tag A0275.
VIOLATION: PROGRAM SCOPE, PROGRAM DATA Tag No: A0273
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on review of facility policies and procedures, medical records, incident logs and staff interviews, facility staff failed to ensure adverse patient events were reported to the hospital's quality assurance and performance improvement program for two of two incidents involving one of one records reviewed with incidents (#2).

The findings include:

Review on 02/23/2012 of facility policy "Incident Reporting and Investigative Procedure" dated 10/2009 revealed "Definitions: Incident - Any event that is not consistent with the normal or expected outcome(s)...Procedure: 1. The employee involved in, observing or discovering the incident and his/her immediate supervisor are responsible for ensuring that an incident report is made as soon as possible after the incident..."

Closed record review on 02/23/2012 of Patient #2 revealed a [AGE] year old who presented to the facility's Emergency Department (ED) on 01/11/2012 at 0948 ambulatory with his mother for a chief complaint of abnormal behavior, difficulty sleeping, confusion and hearing voices. Review revealed the patient was under an Involuntary Commitment Order awaiting bed placement at an acute psychiatric facility.

Interview with security officer staff on 02/23/2012 at 1500 revealed the patient was placed in metal ankle shackles on 01/11/2012 at approximately 2145.

Interview with the security director on 02/22/2012 at 1030 revealed the patient remained in the metal ankle shackles until 01/24/2012 (13 days), with the exception when the patient showered the shackles were removed.

Further review of the record for Patient #2 revealed nursing documentation on 01/18/2012 at 0950 "...Pt's lt (left) ankle (symbol for "with") neosporin (antibiotic ointment) & bandaid (symbol for "after") pt rubbed leg shackles until an abrasion was apparent. Scrubs pulled through cuffs & taped to pad his ankles" (7 days in the metal ankle shackles). Review failed to reveal any documentation of violent behavior as justification for use of shackles as documented at 0950 on 01/18/2012. Review of nursing documentation on 01/18/2012 at 2100 revealed "pt back in room from shower. front of legs at ankle inspected for breakdown. area is reddened. socks pulled up under cuffs...". Review of nursing documentation on 01/24/2012 at 1441 revealed "security officer reports that pt's shackles were removed this am...".

Review on 02/23/2012 of a memorandum dated July 18, 2011 from the security director to "All Security Officer" revealed "A. Each incident requires its own report".

Interview with the security director on 02/22/2012 at 1030 revealed application and monitoring of the metal ankle shackles are the responsibility of the security officers. Interview revealed incidents such as injury while in metal shackles would have an incident report completed. Interview revealed the injury to Patient #2 on 01/18/2012 would have generated an incident report.

Interview with the facility's Chief Nursing Officer on 02/23/2012 at 1550 revealed incidents such as injury while in metal shackles would have an incident report completed. Interview revealed the injury to Patient #2 on 01/18/2012 would have generated an incident report from security or from nursing. Interview revealed there was no incident report filed for the skin breakdown discovered on Patient #2 01/18/2012 related to the metal shackles. Interview failed to reveal any documented evidence an incident report was generated.

Further review of the record for Patient #2 revealed on 01/23/2012 at 0006 the patient was administered Haldol 5mg IM and Trazadone 50mg by mouth for "...agitated, doing calisthenics in rm (room), sweating, wants shower - ED too busy @ present...". Further review revealed at 0110 on 01/23/2012 the patient was administered Ativan 2mg IM with no indication or assessment documented why the patient received the medication. Review revealed at 0115 on 01/23/2012 nursing documentation "To room because pt was yelling and saying he was "stuck". Pt's mouth was open and tongue was protruding. Pt says he can't move his arms and can't move his legs. Pt was diaphoretic and kept saying "I'm stuck, that medicine's got me stuck".

Interview on 02/23/2012 at 1600 with the ED manager revealed the assessment of Patient #2 after receiving the Haldol 5mg IM, Trazadone 50mg oral and Ativan 2mg IM could have potentially been a medication reaction. Interview revealed "I don't believe the staff saw this as a reaction."

Interview with the facility's Chief Nursing Officer on 02/23/2012 at 1550 revealed incidents such as potential medication reactions should generate an incident report. Interview revealed there was no incident report filed for the potential medication reaction on Patient #2 01/23/2012 related to the administration of the medications Haldol 5mg IM, Trazadone 50mg oral and Ativan 2mg IM. Interview failed to reveal any documented evidence an incident report was generated.
VIOLATION: PATIENT SAFETY Tag No: A0286
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on review of facility policies and procedures, medical records, incident logs and staff interviews, facility staff failed to ensure adverse patient events were reported to the hospital's quality assurance and performance improvement program for two of two incidents involving one of one records reviewed with incidents (#2).

The findings include:

Review on 02/23/2012 of facility policy "Incident Reporting and Investigative Procedure" dated 10/2009 revealed "Definitions: Incident - Any event that is not consistent with the normal or expected outcome(s)...Procedure: 1. The employee involved in, observing or discovering the incident and his/her immediate supervisor are responsible for ensuring that an incident report is made as soon as possible after the incident..."

Closed record review on 02/23/2012 of Patient #2 revealed a [AGE] year old who presented to the facility's Emergency Department (ED) on 01/11/2012 at 0948 ambulatory with his mother for a chief complaint of abnormal behavior, difficulty sleeping, confusion and hearing voices. Review revealed the patient was under an Involuntary Commitment Order awaiting bed placement at an acute psychiatric facility.

Interview with security officer staff on 02/23/2012 at 1500 revealed the patient was placed in metal ankle shackles on 01/11/2012 at approximately 2145.

Interview with the security director on 02/22/2012 at 1030 revealed the patient remained in the metal ankle shackles until 01/24/2012 (13 days), with the exception when the patient showered the shackles were removed.

Further review of the record for Patient #2 revealed nursing documentation on 01/18/2012 at 0950 "...Pt's lt (left) ankle (symbol for "with") neosporin (antibiotic ointment) & bandaid (symbol for "after") pt rubbed leg shackles until an abrasion was apparent. Scrubs pulled through cuffs & taped to pad his ankles" (7 days in the metal ankle shackles). Review failed to reveal any documentation of violent behavior as justification for use of shackles as documented at 0950 on 01/18/2012. Review of nursing documentation on 01/18/2012 at 2100 revealed "pt back in room from shower. front of legs at ankle inspected for breakdown. area is reddened. socks pulled up under cuffs...". Review of nursing documentation on 01/24/2012 at 1441 revealed "security officer reports that pt's shackles were removed this am...".

Review on 02/23/2012 of a memorandum dated July 18, 2011 from the security director to "All Security Officer" revealed "A. Each incident requires its own report".

Interview with the security director on 02/22/2012 at 1030 revealed application and monitoring of the metal ankle shackles are the responsibility of the security officers. Interview revealed incidents such as injury while in metal shackles would have an incident report completed. Interview revealed the injury to Patient #2 on 01/18/2012 would have generated an incident report.

Interview with the facility's Chief Nursing Officer on 02/23/2012 at 1550 revealed incidents such as injury while in metal shackles would have an incident report completed. Interview revealed the injury to Patient #2 on 01/18/2012 would have generated an incident report from security or from nursing. Interview revealed there was no incident report filed for the skin breakdown discovered on Patient #2 01/18/2012 related to the metal shackles. Interview failed to reveal any documented evidence an incident report was generated.

Further review of the record for Patient #2 revealed on 01/23/2012 at 0006 the patient was administered Haldol 5mg IM and Trazadone 50mg by mouth for "...agitated, doing calisthenics in rm (room), sweating, wants shower - ED too busy @ present...". Further review revealed at 0110 on 01/23/2012 the patient was administered Ativan 2mg IM with no indication or assessment documented why the patient received the medication. Review revealed at 0115 on 01/23/2012 nursing documentation "To room because pt was yelling and saying he was "stuck". Pt's mouth was open and tongue was protruding. Pt says he can't move his arms and can't move his legs. Pt was diaphoretic and kept saying "I'm stuck, that medicine's got me stuck".

Interview on 02/23/2012 at 1600 with the ED manager revealed the assessment of Patient #2 after receiving the Haldol 5mg IM, Trazadone 50mg oral and Ativan 2mg IM could have potentially been a medication reaction. Interview revealed "I don't believe the staff saw this as a reaction."

Interview with the facility's Chief Nursing Officer on 02/23/2012 at 1550 revealed incidents such as potential medication reactions should generate an incident report. Interview revealed there was no incident report filed for the potential medication reaction on Patient #2 01/23/2012 related to the administration of the medications Haldol 5mg IM, Trazadone 50mg oral and Ativan 2mg IM. Interview failed to reveal any documented evidence an incident report was generated.
VIOLATION: PROGRAM SCOPE, PROGRAM DATA Tag No: A0273
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on review of facility policies and procedures, restraint quality assessment and performance improvement (QAPI) data and staff interviews facility staff failed to ensure effective monitoring of its restraint program.

The findings include:

Review on 02/23/2012 of facility policy "Patient Rights and Responsibilities" dated 01/2010 revealed "Patient Rights - We support the right of each patient:...To receive considerate, respectful, kind and compassionate care, from competent personnel, in an environment that preserves dignity and contributes a positive self-image, avoids unnecessary physical and mental discomfort, and is free from all forms of abuse, neglect..." Further review revealed "Restraint - The patient has the right to be free from physical or chemical restraint that is not medically necessary, or that is used for the purpose of coercion, discipline, convenience or retaliation."

Review on 02/23/2012 of facility policy "Use of Restraints" dated 04/2010 revealed "V. Indications for Violent or Self-Destructive Restraints...Restraints may be ordered and applied for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member or others and alternatives to physical interventions would not be effective...4. Additionally, patients in Violent or Self-Destructive restraints are assessed initially and every fifteen minutes times 4 and then every hour by an RN (registered nurse). At a minimum, assessment should include...Readiness for discontinuation...VI. Documentation - When a restraint is used, the following should be documented in the medical record...A description of the patient's behavior and the interventions used; Alternatives or other less restrictive interventions attempted...The patient's condition or symptoms that warranted the use of restraint; The patient's response to the intervention(s) used, including rationale for continued use..."

Closed record review on 02/23/2012 of Patient #2 revealed a [AGE] year old (date of birth 01/11/1996) who presented to the facility's ED 12/14/2011 at 0404 ambulatory with his family for a chief complaint of "talking out of head...released by Charlotte police (symbol for "secondary to") talking crazy". Review of nursing triage documentation revealed "brought by two cousins - driving truck in hi speed chase (symbol for "with" H.P. in Charlotte." Review of the form "Examination and Recommendation to Determine Necessity for Involuntary Commitment" revealed the patient was made an involuntary commitment (IVC) by the ED physician on 12/14/2011 at 0500 and deemed "mentally ill". Review of the form revealed the physician did not indicate the patient was "dangerous to others" or "dangerous to self". Documentation revealed "(Patient's name) was brought in by family very concerned about patient. For past 2 weeks patient has been displaying psychotic behavior. Talking about death & taking orders from devils, demons & vampires. Patient not sleeping & says he has to stay up @ night to work for the devil. He is having auditory & visual hallucinations, was involved in high speed chase from police 2 days ago. Family fears he is a danger to himself and others." Review of nursing documentation 12/15/2011 at 1000 revealed "Pt requested to use phone, standing (symbol for "with") police officer (hospital security officer) & CNA (certified nursing assistant), threw phone to ground, ran down hallway (symbol for "with") police in chase. Returned to room unharmed, restrained, continues to request phone. Advised no phone @ this time. Medicated as ordered. Lying bed speaking (symbol for "with") CNA...1100...Sleeping...police restraint removed, hospital restraints remain in place...1200 - restraint protocol followed...1300 - eating lunch, one wrist restraint removed...calm...1400 - sleeping...1 leg restraint removed...1450 - sleeping 3 pt ("point" or restraint on three extremities) restraint...1600 - restraints removed by Dr. (name of physician)...1730...Pt watching TV quietly...1800 - Pt finished eating supper (symbol for "without") problem...2050 - Family to see pt. Pt unagitated...2215 - Pt still calmly visiting (symbol for "with") family...2245 - Pt still tolerating restraint (symbol for "without") increased agitation...2330 - Pt sitting up on end of bed...Pt holding onto end of bed...2340 - Pt standing up @ door...0053 - Pt awake. Restraints remain on one foot...0056 - Restraint D/C'd (discontinued)" Further review of nursing documentation on 12/16/2011 at 0226 revealed "Per Dr. (name of physician), restraints not medically necessary (symbol for "secondary") to pt not displaying threatening behavior. Pt up pacing in room. Pt doing pushups on floor..." Review of nursing documentation on 12/16/2011 at 0700 revealed "...Pt resting bed. Sitter & officer @ bedside...0745 - Dr. (name of physician) asked if restraints could be restarted. Dr. (name of physician) declined restraint order...0830 - Pt to bathroom...Pt appears cooperating...". Further review of documentation on 12/16/2012 at 0900 revealed "pts breakfast arrives, pt somewhat less restless...(hospital security officer) placed legs in cuffs on pt..." Review of physician restraint orders revealed restraints were ordered on [DATE] at 0955 with a physician's order to renew restraints at 1155, 1355, 1555, 1755, 1955, and 2155. Review of the "Violent or Self Destructive Restraint Care Flow Sheet" revealed the patient was in restraints from 0955 on 12/15/2011 until 0055 on 12/16/2011. Further review of the row "Restraint still indicated for Behavior Management Reasons" on the restraint flow sheet failed to reveal a behavior code, as indicated on the flow sheet, to justify continuance of the restraints. Review revealed the patient was transferred to an acute psychiatric hospital 12/16/2011 at 1350.

Interview on 02/23/2012 at 1600 with the ED manager revealed patients should only be restrained in order to ensure the immediate safety of the patient and staff and should be discontinued at the earliest possible time. Interview revealed during the 12/14/2011 visit, the patient attempted to elope, however, was "tackled" in the ED parking lot and had to be "dragged back into the ED" and was placed in metal handcuffs by the hospital security officer. Interview revealed all hospital security officers are sworn police officers or sheriff's deputies. Interview revealed the documentation revealed the patient was in the metal handcuffs and four point hospital restraints for one hour until the metal handcuffs were removed. Interview revealed the patient was in the hospital restraints from 0955 on 12/15/2011 until 0055 on 12/16/2011 (15 hours in restraints). Interview revealed the documentation failed to reveal evidence how many extremities were restrained during each monitoring cycle (at least every one hour). Interview revealed documentation failed to reveal alternatives attempted prior to initiation of restraints, justification for initiation and justification of continuance of restraint for 15 continuous hours beginning 12/15/2011 at 0955. Review of documentation failed to reveal a justification for the patient's leg to be cuffed. Interview revealed staff failed to follow facility policy regarding a patient's right to be free of restraint by failing to ensure restraint was discontinued at the earliest possible time on 12/15/2011.

Interview on 02/23/2012 at 1345 with the Emergency Department (ED) Clinical Educator #1 revealed this staff member is responsible for restraint Quality Assessment and Performance Improvement (QAPI) monitoring for the ED. Interview revealed the restraint episode for Patient #2 on 12/15/2012 beginning at 0955 and ending 12/16/2011 at 0055 had been reviewed for quality. Interview revealed based on the current indicators being utilized for restraint review in the ED, there were no areas of concern related to the restraint episode with Patient #2. Interview revealed the deficient areas realized through record review on 02/23/2012 and interview with the ED manager were not found since the ED restraint QAPI program was not currently monitoring for assessment of justification for restraint, alternatives attempted prior to restraint, assessment for behaviors indicating continuance of restraint, documentation of the extremities restrained, and use of metal handcuff/ ankles shackles by the facility's security officers.
VIOLATION: NURSING SERVICES Tag No: A0385
Based on facility policy and procedure reviews, medical record reviews, observations during tour, emergency equipment log reviews, defibrillator shift summary printout review, and staff interviews the facility failed to have an effective nursing service providing oversight and supervision of day to day operations by failing to ensure nursing staff: performed ongoing patient assessments for patients in restraints; supervised the testing of emergency equipment; ensured medications were administered as ordered by a physician; and ensured verbal orders were transcribed and authenticated per policy.

The findings include:

1. The facility's nursing staff failed to ensure ongoing patient assessment of 1 of 1 records reviewed of patients in metal ankle shackles (Forensic Restraints) for 13 consecutive days and developed skin breakdown on day 7 (Patient #2) and failed to supervise the testing of emergency equipment in patient care areas per facility policy.

~cross refer 482.23(b)(3) Nursing Services - Supervision of Nursing Care - Standard Tag A0395.

2. The facility's nursing staff failed to ensure medications were administered as ordered by a physician for 1 of 7 records reviewed (Patient #2).

~cross refer 482.23(c) Nursing Services - Administration of Drugs - Standard Tag A0404.

3. The facility's nursing staff failed to ensure verbal orders for medications were transcribed and authenticated per facility policy for 1 of 1 patient records reviewed (Patient #2), who was restrained with metal ankle shackles (Forensic Restraints).

~cross refer 482.23(c)(2)(ii) Nursing Services - Verbal Orders - Standard Tag A0408.
VIOLATION: RN SUPERVISION OF NURSING CARE Tag No: A0395
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on facility policy and procedure reviews, medical record reviews, observations during tour, emergency equipment log reviews, defibrillator shift summary printout reviews, and staff interviews the facility's nursing staff failed to ensure ongoing patient assessment of 1 of 1 records reviewed of patients in metal ankle shackles (Forensic Restraints) for 13 consecutive days and developed skin breakdown on day 7 (Patient #2) and failed to supervise the testing of emergency equipment in patient care areas per facility policy.

The findings include:

1. Review on 02/23/2012 of facility policy "Use of Restraints" dated 04/2010 revealed "V. Indications for Violent or Self-Destructive Restraints...Restraints may be ordered and applied for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member or others and alternatives to physical interventions would not be effective...4. Additionally, patients in Violent or Self-Destructive restraints are assessed initially and every fifteen minutes times 4 and then every hour by an RN (registered nurse). At a minimum, assessment should include: Signs of any injury associated with the application of the restraint; Physical and psychological status and comfort; and readiness for discontinuation of restraint."

Closed record review on 02/23/2012 of Patient #2 revealed a [AGE] year old who presented to the facility's Emergency Department (ED) 01/11/2012 at 0948 ambulatory with his mother for a chief complaint of abnormal behavior, difficulty sleeping, confusion and hearing voices. Review of the form "Examination and Recommendation to Determine Necessity for Involuntary Commitment" revealed the patient was made an involuntary commitment (IVC) by the ED physician on 01/11/2012 at 1000 and deemed "mentally ill" and "dangerous to self". Review of the form revealed the physician did not indicate the patient was "dangerous to others". Further review revealed the IVC was renewed on 01/18/2012 at 0900 and the examining physician indicated the patient was "mentally ill" and "dangerous to self". Review of the form revealed the physician did not indicate the patient was "dangerous to others". Review of nursing documentation on 01/12/2012 at 2130 revealed "Pt (patient) family visiting, brought pt McDonalds. Pt has not (symbol for "increased") agitation...2240 - Pt trembling, attempting to pace room and fidget (symbol for "with") shackles. (Physician name) made aware. Ativan (anti-anxiety medication) 2mg (milligrams) po (oral)...2337 - Pt resting quietly in bed, calm and cooperative at this time. Trazadone (anti-psychotic medication) 50mg po given..." Review of nursing documentation on 01/14/2012 at 2105 revealed "...Shackles on ankles...". Review failed to reveal any documentation of violent behavior as justification for use of shackles as documented at 2105 on 01/14/2012. Review of nursing documentation on 01/18/2012 at 0950 revealed "...Pt's lt (left) ankle (symbol for "with") neosporin (antibiotic ointment) & bandaid (symbol for "after") pt rubbed leg shackles until an abrasion was apparent. Scrubs pulled through cuffs & taped to pad his ankles." Review failed to reveal any documentation of violent behavior as justification for use of shackles as documented at 0950 on 01/18/2012 and failed to reveal the physician was notified the patient had an injury related to the metal shackle restraint. Review of nursing documentation on 01/18/2012 at 2100 revealed "pt back in room from shower. front of legs at ankle inspected for breakdown. area is reddened. socks pulled up under cuffs...". Review of nursing documentation on 01/24/2012 at 1441 revealed "security officer reports that pt's shackles were removed this am...". Record review failed to reveal ongoing hourly assessments of restraint as outlined in the facility policy. Review revealed the patient was transferred from the facility's emergency department to an acute psychiatric hospital on [DATE].

Interview on 02/23/2012 at 1300 with an ED physician who documented on Patient #2s record on 01/18/2012 revealed the physician saw the patient on 01/18/2012 to reorder one of the patient's home medications. Interview when asked about Patient #2 being in the metal ankle shackles revealed "I had nothing to do with that (the metal ankle shackles)." Interview revealed "I had minimal interaction with him (Patient #2)." Interview revealed the physician had no knowledge of the metal ankle shackles causing any injury to Patient #2 on 01/18/2012.

Interview on 02/22/2012 at 1720 with the patient's primary nurse on 01/18/2012 revealed the RN assessed Patient #2 to have reddened ankles and an abrasion to the lateral aspect of the left ankle from the shackles rubbing against the patient's legs. Interview revealed the RN did not recall reporting the injury to the physician. Documentation review during the interview failed to reveal any documentation the physician was notified of the injury related to the metal ankle shackles used as a restraint.

Interview on 02/22/2012 at 1735 with a staff RN in the ED revealed the RN was the primary nurse assigned to care for Patient #2 for many of her shifts during the patient's stay from 01/11/2012 through 01/25/2012. Review of documentation revealed the RN was assigned patient #2 on the night of 01/11/2012 and 01/19/2012. Interview revealed the patient was in the metal ankle shackles every shift she was there "security would remove the shackles for him (Patient #2) to shower, and then put them back on...they (security) were responsible for the shackles." Interview revealed the RN knew of no staff request made of security to have the metal ankle shackles removed. Interview revealed the metal ankle shackles were "the responsibility of the security officers." Interview revealed the ED nursing staff would not be required to document an ongoing hourly assessment of the patient since the shackles were placed by security.





2. Review of current facility policy "Defibrillator Check Policy" reviewed March 2010, revealed "Standard: All defibrillators will be checked for proper functioning and supplies for adequacy. Staff Outcome: The RN (or other designated staff) will check the defibrillator and supplies for their area, record their findings on the check sheet, and notify Biomed or the Administrative Nurse Supervisor (nights/weekends) if the defibrillator is not functioning properly. ..."

Observations during tour on 02/23/2012 at 1100 of the emergency department (ED) "Convenience Care" area revealed an Agilent Heartstream cardiac monitor/defibrillator being stored on the counter top in exam room #19. Observation revealed a printer port on the top of the device. Observation revealed attached to the device's printer port was a "Shift/System Check" summary printout. Review of the "Shift/System Check" summary printout for "Serial Number: US 926" revealed documentation the last date and time the device was tested was on "20 [DATE]:46:54" (3 days prior). Review of the "Emergency Equipment Checksheet" daily log for the week of 02/20/2012 to 02/26/2012 revealed documentation by multiple nursing staff the device had been checked three (3) times on 02/21/2012 and three (3) times on 02/22/2012. Further observation of a demonstration by an ED nurse of the procedure for performing the daily shift check for the device revealed when tested the printer of the device was functioning and a "Shift/System Check" summary printout was printed by the device. Subsequently, observations revealed the device had not been tested since 02/20/2012 (3 days prior), yet nursing staff had documented a test was performed on 02/21/2012 and 02/22/2012. Interview during tour with ED Nursing Management Staff revealed the defibrillator/monitor in room #19 was available for patient use. Interview revealed the charge nurse is responsible for ensuring the device is checked every shift. Interview revealed the device is to be "fired" once per day and documented on the check sheet by the charge nurse. Interview confirmed the "Shift/System Check" printout attached to the device documented the last check was on 02/20/2012. Interview confirmed the nursing staff documented a check performed on 02/22/2012 and 02/23/2012. Interview revealed "I am so disappointed in the staff, they are better than that." Interview confirmed the charge nurse failed to supervise the testing of the defibrillator per facility policy.
VIOLATION: ADMINISTRATION OF DRUGS Tag No: A0405
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on review of facility policies and procedures, medical records and staff interviews, nursing staff failed to ensure medications were administered as ordered by a physician for 1 of 7 records reviewed (#2).

The findings include:

Review on 02/23/2012 of facility policy "Standards for Medication Ordering, Transcription, and Administration" dated 09/2010 revealed "Patient Outcomes: The correct medication is administered..at the correct time...receive an accurate assessment of drug indications, followed by evaluation of therapy and correct documentation." Further review revealed "Ordering: 1. Medications are administered only upon the order of a physician, dentist, or approved non-physician who has current privileges. All telephone/verbal medication orders are written on the physician order sheet and signed by the physician within 48 hours after the order is given...II. Clear, legible, and complete medication orders include...indications for use, if a prn (as needed) medication...date...signature of physician...VII. Verbal and telephone orders...are written on the physician order sheet with the name of the physician giving the order..."

Closed record review on 02/23/2012 of Patient #2 revealed a [AGE] year old who presented to the facility's Emergency Department (ED) on 01/11/2012 at 0948 ambulatory with his mother for a chief complaint of abnormal behavior, difficulty sleeping, confusion and hearing voices. Review of physician's orders in the ED revealed a verbal order at 2245 "Haldol (antianxiety medication) 5mg (milligrams) IM (intramuscular) q4h (every four hours) prn agitation x (times) 3 doses, 1/11 (January 11, 2012) #1 (first dose) given 2245." Review of the Medication Administration Record (MAR) revealed the patient received #2 dose of Haldol 5mg IM on 01/12/2012 at 1605 for anxiety and #3 on 01/12/2012 at 2010 for anxiety. Further MAR review revealed the patient received Haldol 5mg IM on 01/13/2012 at 2150 for "rest", on 01/14/2012 at 2105 for "pacing around room" and on 01/15/2012 at 2330 as a "night time medicine". Review of physician orders failed to reveal another verbal physician's order, transcribed by nursing staff, for Haldol 5mg IM until 01/17/2012 (last written on 01/11/ for three doses). Review revealed the three doses of Haldol 5mg IM administered on 01/13/2012, 01/14/2012, and 01/15/2012 were given without a physician's order and were administered for reasons other than the original order (on 01/11/2012) for "agitation". Review of the verbal physician's order for Haldol 5mg IM written 01/17/2012 by nursing staff revealed the order failed to have an indication for the administration of the PRN medication. Review of the MAR revealed Haldol 5mg IM was administered 01/17/2012 at 1119 with no indication or assessment why the medication was administered. Further review revealed no evidence of any reassessment of the medication's effectiveness after being administered 01/17/2012 at 1119. Review revealed Haldol 5mg IM was administered 11/18/2012 at 2325 for "...Pt request night meds so he can sleep." Review revealed the Haldol 5mg IM was administered with an unauthenticated verbal order with no indication documented. Record review revealed Haldol 5mg IM was administered 01/22/2012 at 1605. Further review revealed no evidence of any reassessment of the medication's effectiveness after being administered 01/22/2012 at 1605. Review revealed on 01/23/2012 at 0006 the patient was administered Haldol 5mg IM and Trazadone 50mg by mouth for "...agitated, doing calisthenics in rm (room), sweating, wants shower - ED too busy @ present...". Further review revealed at 0110 on 01/23/2012 the patient was administered Ativan 2mg IM with no indication or assessment documented why the patient received the medication. Review revealed at 0115 on 01/23/2012 nursing documentation "To room because pt was yelling and saying he was "stuck". Pt's mouth was open and tongue was protruding. Pt says he can't move his arms and can't move his legs. Pt was diaphoretic and kept saying "I'm stuck, that medicine's got me stuck".

Interview on 02/23/2012 at 0930 with ED RN staff revealed the RN administered the Haldol 5mg IM on 01/17/2012 at 1119. Record review during the interview revealed the RN failed to indicate why the medication was administered and failed to reassess the effectiveness of the medication.

Interview on 02/23/2012 at 1600 with the ED manager revealed medications should only be administered under the order of a physician. Interview failed to reveal any documented evidence a physician's order was written for the Haldol 5mg IM administered on 01/13/2012, 01/14/2012, and 01/15/2012 and were administered without an appropriate indication for "rest" on 01/13/2012, "night time medicine" on 01/15/2012 and "Pt request night meds so he can sleep" on 01/18/2012 at 2325. Interview revealed staff failed to follow facility policy by failing to accept a verbal order for a PRN "as needed" medication without an indication on 01/17/2012 for the Haldol 5mg IM. Further interview revealed staff failed to follow facility policy by failing to indicate why the medication Haldol 5mg IM was administered on 01/17/2012 at 1119 as well as Ativan 2mg IM at 0110 on 01/23/2012.
VIOLATION: VERBAL ORDERS Tag No: A0408
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on review of facility policies and procedures, medical records and staff interviews, the facility's nursing staff failed to ensure verbal orders for medications were transcribed and authenticated per facility policy for 1 of 1 patient records reviewed (Patient #2), who was restrained with metal ankle shackles (Forensic Restraints).

The findings include:

Review on 02/23/2012 of facility policy "Standards for Medication Ordering, Transcription, and Administration" dated 09/2010 revealed "Ordering: 1. Medications are administered only upon the order of a physician, dentist, or approved non-physician who has current privileges. All telephone/verbal medication orders are written on the physician order sheet and signed by the physician within 48 hours after the order is given...II. Clear, legible, and complete medication orders include...indications for use, if a prn (as needed) medication...date...signature of physician...VII. Verbal and telephone orders...are written on the physician order sheet with the name of the physician giving the order..."

Closed record review on 02/23/2012 of Patient #2 revealed a [AGE] year old who presented to the facility's Emergency Department (ED) on 01/11/2012 at 0948 ambulatory with his mother for a chief complaint of abnormal behavior, difficulty sleeping, confusion and hearing voices. Review of the physician's orders revealed numerous verbal orders for medications transcribed by nursing staff on three different "Physician's Order Sheets". Review of physician order Sheet #1 revealed verbal orders received on 11/11/2012, 01/12/2012 and 01/13/2012 with no physician name who gave each order and only one physician signature with no date indicating when the physician authenticated the order sheet. Review of physician order Sheet #2 revealed verbal orders received on 01/14/2012, 01/15/2012, 01/16/2012, 01/17/2012, and 01/18/2012 with no physician name who gave each order and only one physician signature with no date indicating when the physician authenticated the order sheet. Review of physician order Sheet #3 revealed verbal orders received on 01/21/2012, 01/22/2012, and 01/24/2012 with no physician name who gave each order and only one physician signature with no date indicating when the physician authenticated the order sheet. Further review of physician order Sheet #3 revealed orders with the prescribing physician, but no date indicating the when the verbal order was received and transcribed.

Interview on 02/23/2012 at 1600 with the ED manager revealed all verbal orders should indicate the date, time and physician giving the order. Interview revealed the verbal orders received on the dates in the record review were incomplete and not per facility policy. Interview revealed there were physician signatures missing authenticating the verbal orders given. Interview revealed " We do not have a good system when a patient has an extended stay (in the Emergency Department)".
VIOLATION: SECURE STORAGE Tag No: A0502
Based on facility policy and procedure review, observations during tours, and staff interviews the facility failed to ensure medications were kept in a secure area and locked when not in use by authorized staff and failed to ensure medications stored in crash carts were secured, locked, and not accessible to patients/visitors/family members when not in use by authorized staff within patient care areas.

The findings include:

1. Review of current facility policy "Medication Security" Policy #05-27, dated 04/2010, revealed "....Medication Storage Areas (outside of pharmacy) Medication storage areas outside of the pharmacy include medication carts, automated dispensing cabinets, medication rooms, crash carts, supply rooms, procedure rooms, etc. All medication storage areas shall be locked when unattended;.... ...Access to locked medication rooms is limited to pharmacy staff and persons authorized to handle and administer medications contained in theses areas (nurses, respiratory therapists, and nursing messengers). Other staff may be granted access to the medication room in conjunction with their duties and while under direct supervision of authorized staff. ..."

Observations during tour on 02/23/2012 at 1045 of the emergency department (ED) "Convenience Care" area revealed a medication room located behind the nursing station. Observation revealed the medication room did not have a door. Observation revealed the Convenience Care (CC) area of the ED was closed (normal hours from 1100-2300). Observation revealed no patients within the CC exam rooms. Observation revealed no authorized ED staff present supervising the medication room. Observation inside the medication room revealed the following injectable and topical medications being stored unsecured in line-of-eye-sight on-top of the counter in a red plastic bin: 1. (one) multidose vial of Lidocaine 1% with epinephrine injectable; 2. (one) tube Triple antibiotic topical ointment; 3. (two) tubes Lidocaine 2% topical ointment; and 4. (one) tube Benzocaine 20% Topical Anesthetic. Further observation revealed a refrigerator used to store medications under the countertop. Observation revealed no locking mechanism to secure the refrigerator. Observation revealed when opened the refrigerator contained the following oral medications: 1. (one) Amoxicillin and Clavulanate Potassium 250 milligrams (mg)/62.5 mg; 2. (one) Amoxicillin 250 mg/5 milliliters (ml); and 3. (one) Berry Smoothie - Redi Cat-2 Barium Sulfate Suspension. Further observation revealed an environmental services technician (housekeeping) performing work duties in proximity to the medication room. Observation revealed pedestrian traffic in proximity to the medication room. Observation revealed the medications were being stored unsecured and not supervised by authorized staff. Interview during the tour with ED Nursing Management Staff revealed the Convenience Care side of the ED was currently closed. Interview revealed the medications should not be stored on-top of the counter in the medication room unsecured. Interview revealed only authorized staff should have access to the medications. Interview confirmed the medications were being stored unsecured and were not being supervised by authorized staff.

2. Review of current facility policy "Pediatric Emergency Cart/Transfer Bag" revised 04/2008, revealed "Standard: The integrity of each Pediatric Emergency Cart....will be maintained by checking lock integrity and the expiration date of the bag each shift and by following a systematic method for restocking the cart/transfer bag after it has been opened. Staff/Patient Outcome Through verification of lock integrity and cart....contents, staff will ensure all equipment and medications are readily available in an emergency situation. ..."

Review of current facility policy "Adult Crash Carts Restocking, Cleaning and Maintaining Integrity" revised 02/2010, revealed "...Supportive Data: 1. All crash carts are kept locked unless in active use for an emergency situation. ..."

Observations during tour on 02/23/2012 at 1115 of the main emergency department (ED) revealed trauma room #1. Observation revealed a pediatric crash cart being stored in trauma room #1. Observation revealed the pediatric crash cart had a metal bar hinge (approximately 24-36 inches long) attached to the right side of the crash cart. Observation revealed the metal bar hinge was in the closed position and covering the right side corners of each drawer of the cart. Observation revealed the metal bar hinge had an opening in the bar to allow a metal tab to protrude through the bar in order to affix a green security lock (# 52). Further observation revealed an electronic locking mechanism at the top of the cart to secure the medication and supplies drawers. Observation revealed the surveyor was able to open the metal bar hinge and access the emergency medications stored in drawer #1 without breaking the integrity of the security lock. Observation revealed the electronic locking mechanism failed to secure the medication drawer. Observation revealed a patient and family member occupying the trauma room. Observation revealed privacy curtains in use that blocked direct visualization of the trauma room from the nursing station. Observation revealed the patient and family member in the trauma room were not being constantly supervised by nursing staff. Observation revealed the pediatric crash cart was within close proximity of the family member and patient. Observation revealed the medications in the crash cart were unsecured. Interview with ED Nursing Management staff during tour revealed the crash cart's medications and supplies "should be secure." Interview revealed the electronic locking mechanism on the crash cart runs off batteries. Interview revealed "it must have a low or dead battery." Interview revealed the cart should have locked the medication and supplies drawers. Interview revealed the purpose of the security lock is to ensure the crash cart's medications and emergency supplies are present and have not been tampered with or removed. Interview revealed the pediatric crash cart was used on the previous shift and staff had temporarily placed a green security lock on the crash cart instead of the red lock provided by pharmacy. Interview revealed the red locks are more rigid and less flexible and will break open when the metal bar hinge on the pediatric crash cart is opened. Interview confirmed the staff was unable to verify if any medications or supplies had been removed from the crash cart since the application of security lock # 52. Interview revealed "we need to review our process."
VIOLATION: FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE Tag No: A0724
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on facility policy and procedure reviews, observations during tour, and staff interviews, the facility's nursing staff failed to follow procedures for testing emergency equipment per policy; failed to ensure equipment used for patient care did not have cracks/tears/holes in the outer protective surfaces; and failed to ensure sharps used for intravenous (IV) access, injections, venipuncture, and intramuscular injections were stored in a safe manner on patient care units.

The findings include:

1. Review of current facility policy "Defibrillator Check Policy" reviewed March 2010, revealed "Standard: All defibrillators will be checked for proper functioning and supplies for adequacy. Staff Outcome: The RN (or other designated staff) will check the defibrillator and supplies for their area, record their findings on the check sheet, and notify Biomed or the Administrative Nurse Supervisor (nights/weekends) if the defibrillator is not functioning properly. ..."

Observations during tour on 02/23/2012 at 1100 of the emergency department (ED) "Convenience Care" area revealed an Agilent Heartstream cardiac monitor/defibrillator being stored on the counter top in exam room #19. Observation revealed a printer port on the top of the device. Observation revealed attached to the device's printer port was a "Shift/System Check" summary printout. Review of the "Shift/System Check" summary printout for "Serial Number: US 926" revealed documentation the last date and time the device was tested was on "20 [DATE]:46:54" (3 days prior). Review of the "Emergency Equipment Checksheet" daily log for the week of 02/20/2012 to 02/26/2012 revealed documentation by multiple nursing staff the device had been checked three (3) times on 02/21/2012 and three (3) times on 02/22/2012. Further observation of a demonstration by an ED nurse of the procedure for performing the daily shift check for the device revealed when tested the printer of the device was functioning and a "Shift/System Check" summary printout was printed by the device. Subsequently, observations revealed the device had not been tested since 02/20/2012 (3 days prior), yet nursing staff had documented a test was performed on 02/21/2012 and 02/22/2012. Interview during tour with ED Nursing Management Staff revealed the defibrillator/monitor in room #19 was available for patient use. Interview revealed the charge nurse is responsible for ensuring the device is checked every shift. Interview revealed the device is to be "fired" once per day and documented on the check sheet by the charge nurse. Interview confirmed the "Shift/System Check" printout attached to the device documented the last check was on 02/20/2012. Interview confirmed the nursing staff documented a check performed on 02/22/2012 and 02/23/2012. Interview revealed "I am so disappointed in the staff, they are better than that." Interview confirmed the nursing staff failed to follow policy.

2. Observations during tour on 02/23/2012 from 1011 to 1130 of the emergency department revealed the following equipment for patient use with cracks/tears/holes in the outer protective surfaces: 01) Triage Room #2 - recliner chair, visible cracks/tears/holes in the left chair arm surface. 02) Triage Room #3 - recliner chair, visible cracks/tears/holes in the front leg surfaces. 03) Convenience Care Room #17 - stretcher mattress, visible cracks/tears/holes in surface, patient side. 04) Main ED exam room #8 - stretcher mattress, visible cracks/tears/holes in surface, patient side. Interview during tour with the ED Nursing Management Staff revealed the staff should not be using recliners and mattresses with cracks/tears/holes in them for patient care. Interview revealed the hospital does not have a policy regarding cracks/tears/holes in patient mattresses and recliners. Interview revealed the practice is to remove them from service when they have been discovered. Interview confirmed this was a safety and infection control issue.

3. Review of current facility policy "Handling and Storage of Clean and Sterile Supplies" Policy #3.01, dated 08/2009, revealed "Policy: Clean and sterile supplies and equipment will be handled and stored in a safe manner. ..."

Observations during tour on 02/23/2012 at 1045 of the emergency department's (ED) "Convenience Care (CC)" area revealed the area was closed (normal hours from 1100-2300). Observation revealed no patients within the CC exam rooms. Observation revealed no nursing staff on-duty in the CC area. Observation revealed a medication room located behind the nursing station. Observation revealed the medication room did not have a door. Observation inside the medication room revealed five (5) IV start trays being stored on the counter and a Mayo stand. Observation revealed a plastic bin with (5) drawers containing 16 to 25 gauge needles stored on the counter. Observation revealed IV access catheters 16 to 24 gauge and needs 16 to 25 gauge with syringes being stored in the IV start trays. Observation revealed the sharps were unsecured and in a visible line-of-sight. Further observation revealed an environmental services technician (housekeeping) performing work duties in proximity to the medication room. Observation revealed pedestrian traffic in proximity to the medication room. Observation revealed the sharps were being stored unsecured and not supervised by staff. Interview during the tour with ED Nursing Management Staff revealed the Convenience Care side of the ED was currently closed. Interview revealed the sharps should not be stored on-top of the counter or on the Mayo stand in the medication room unsecured. Interview revealed only authorized staff should have access to sharps. Interview confirmed the sharps were being stored unsecured and were not being supervised by authorized staff. Interview confirmed the sharps should have been stored in a safe manner.

NC 360