HospitalInspections.org

Based on observation, interview and record review the facility:

- Failed to ensure two of two patients reviewed (Patients #15 and #16) with restraints were afforded the right to be free from restraints as evidenced by staffs' failure to compehensively assess, re-assess and/or implement the least restrictive device (A154, A164);
- Failed to remove the restraint completely and assess for injury at regular intervals and prior to discharge (A154);
- Failed to follow their facility policy regarding restraint use (A167);
- Failed to renew an order for restraints after an initial four-hour period of restraint (Patient #15) (A171);
- Failed to complete a one-hour face-to-face evaluation related to use of restraints for management of behavioral symptoms in the Emergency Department (ED) (A178).

Due to the severity of the situation and the potential harm to all ED patients in the facility, this resulted in overall noncompliance with the Condition of Participation of Patient Rights CFR 482.13.

Based on record review and interview, the facility failed to ensure information and disclosures were provided to Patients before any medical procedures or treatments. The facilities Policy and Procedures contain exceptions to the requirement for informed consent which allows a physician to withhold information from a patient and/or believes the patient has knowledge of a proposed procedure or treatment. All Patients' or their legal representative must be given the information and disclosures needed to make an informed decision about whether to consent to a procedure, intervention, or type of care that requires consent before the patient receives a medical procedure, intervention or is asked to sign a consent form. This has the potential to affect all patients in the hospital. The facility also failed to obtain consent from three patients' (#3, #4, and #15) of eight medical charts reviewed. The facility census was 28.

Findings included:

1. Record review of the facility's policy titled, "ADMINISTRATIVE MANUAL", numbered 14-5400-03 and revised 07/01/2009, showed the following direction to hospital staff:
SUBJECT: Patient Consent/Informed Consent,
The Responsibility of Staff in Obtaining
UNITS PRIMARILY AFFECTED:
All Departments responsible for obtaining permits
PURPOSE: To define for staff their responsibility in the patient consent process.
POLICY/STANDARD OF CARE:
- An authorization for medical care form is to be properly executed at the time of admission, or as soon as possible.
- The Physician retains responsibility for explaining treatment modalities, blood product transfusions, diagnostic procedures, surgical procedures and the potential complications, risks, benefits and alternatives to patients.
- The patient's signed consent must be obtained before treatment is performed.
- The signed informed consent form is placed in the medical record.
- Exceptions to the Informed Consent Requirement:
There are recognized exceptions to the requirement for informed consent.
b. THERAPEUTIC PRIVILEGE
The therapeutic privilege allows a physician to withhold information from a patient where it is believed that more harm will result by disclosing that information. To defend an assertion of therapeutic privilege, there must be strong evidence that the truth will create a greater harm to the patient than the withholding of information. It is important to recognize that withholding information may interfere with the patient's ability to make an informed decision.
d. PRIOR PATIENT KNOWLEDGE
If it is known that the patient has knowledge about the proposed procedure or treatment because of previous personal experiences, or because the elements constituting informed consent are within common knowledge, providing information is not necessary prior to obtaining informed consent. The patient record should reflect how the patient is knowledgeable and some verification that the patient has the necessary information to make an informed decision.

2. Record reviews of two patients' (#3 and #4) medical records on 06/21/11 showed the facility consent form in the medical records but the consent forms did not contain an authorized signature and the signature line was blank. Patient #3 was admitted to the facility on 06/18/11 and patient #4 was admitted to the facility on 06/19/11.

3. During an interview on 06/23/11 at 3:30 PM, Staff X, Chief Executive Officer, stated it would be difficult to make an informed decision if you weren't given all of the information to be informed of the risks or consequences of that decision.





12450

4. Review of Patient #15's Emergency Department (ED) Summary Report, dated 04/14/11, showed the patient presented at 3:13 PM due to increased behavioral disturbances. The patient remained in the ED until transferred to another hospital at 11:30 PM.

Review of the patient's guarantor information, dated 04/14/11, showed a "family/other" to notify for questions or further information.

Review of Patient #15's Consent to Medical and Surgical Procedures, dated 04/14/11, showed a blank authorized signature line.

Review of the entire ED records, dated 04/14/11, showed staff consistently failed to contact the patient's designee for a signature on the Consent form. This was confirmed via interview with the ED physician on 06/24/11 at 9:22 AM.

Based on observation, the facility failed to ensure privacy for all patients placed on the Medical Floor. Patients' privacy, name and location, was violated by using the full first and last names posted on the outside of every patient room in full view of other patients, visitors and the general public for 15 patients (#3, #4, #5, #6, #7, #13, #17, #18, #19, #20, #21, #22, #23, #24, and #25) of 15 patients on the Medical Floor. The facility census was 28.

Findings included:

1. Observations on 06/21/11 at 2:20 PM and 06/22/11 at 8:26 AM on the Medical Floor showed each Patient's full first and last names posted on the outside of their doors. The names were printed very clearly with black ink on white paper and posted at eye level in the public hall on the left side of each room entry. The posting of the patient's full name allowed anyone on the Medical Floor to have knowledge that the person was being medically treated in the facility and the location of the person in the facility.

2. During a telephone interview on 06/30/11 at 11:47 AM with Staff B, Registered Nurse (RN), Assistant Administrator of Patient Care Services, stated that the physicians requested the full names of patients to be posted so they could more easily locate their patients.

Based on observation, interview and record review the facility failed to ensure two of two patients reviewed (Patients #15 and #16) with restraints were afforded the right to be free from restraints as evidenced by staffs' failure to assess, re-assess and/or implement the least restrictive device, failed to remove the restraint completely and assess for injury at regular intervals and prior to discharge, failed to develop a care plan in relation to use of the restraints, failed to follow their own policy regarding restraint use, failed to renew an order for restraints after an initial four-hour period of restraint (Patient #15), failed to discontinue at the earliest possible time, failed to complete a one-hour face-to-face evaluation, and failed to ensure two of three staff reviewed were trained related to use of restraints for management of behavioral symptoms in the Emergency Department (ED). The facility identified two patients restrained in the prior six months. The facility census was 28.

Findings Included:

1. Review of a facility policy entitled, "Restraints, Use of," revised 09/2009, showed the following:

-All patients have the right to be free from restraints, of any form, imposed as a means of coercion, discipline, convenience or retaliation;
-The use of a restraint is a last resort when lest restrictive interventions (hand mittens attempted before soft extremity restraint; 2-point soft restraint before body net; sitter or request family members to stay with patient) have been determined to be ineffective to ensure the safety of the patient, staff or others;
-Restraint must be discontinued at the earliest possible time;
-A restraint is a medication when it is used as a restriction to manage the patient ' s behavior and is not a standard treatment for the patient ' s condition;
-The patient must be seen face-to-face within one hour after initiation of the behavioral restraint to evaluate the patient ' s reaction, medical and behavioral condition, and the need to continue or terminate the restraint;
-Renew behavioral restraint orders every four hours for adults by the Registered Nurse (RN) contacting the physician and report the results of his/her most recent assessment and request the original order be renewed.

During an interview on 06/23/11 at 10:45 AM, Paramedic Staff V, stated his ambulance was sent to a local nursing home (NH) on 04/14/11 to pick up patient #15 and transport to the local ED. Staff V stated the patient was able to stand and pivot to the ambulance cot. The patient was very active, tried to remove the cot belt and reached out, but his/her reactions were slowed as he/she had received Ativan (an anti-anxiety medication) prior to the ambulance crews arrival. Staff V did not note any bruising or injury to the patient's skin.

Review of Patient #15's ED nursing assessment showed the following:

-Patient #15 presented to the ED, via ambulance, on 04/14/11 at 2:21 PM, and was triaged at 2:38 PM;
-The patient had a history of combativeness and confusion related to dementia, and his/her left eye was sutured shut related to a recent cornea surgery;
-The patient typically received some anti-psychotic and anti-anxiety type medications (Seroquel, Zyprexa and Ativan) at the NH for behaviors, but these behaviors had increased in the prior two to three days;
-The patient had not received Haldol in the NH (an anti-psychotic medication that is to be used cautiously in elderly and debilitated patients-usually used for delirium [an acute mental disorder characterized by fear, anxiety and often illusions/delusions]);
-The patient was uncooperative and combative per nurses' notes within the assessment;
-Staff failed to document the patient's skin condition at admission.

Review of the ED physician's assessment, dated 04/14/11, showed multiple skin tears to one of the patient ' s hands, but no other skin problems/injuries.

Review of ED Medication Administration Records and Physician's Orders showed the following:

-At 2:30 PM staff placed Patient #15 in a full body net restraint (FBN-a cloth, netting type restraint that has multiple heavy cloth straps and velcro restrictive areas from the neckline to the knees of the patient-this restraint restricts movement of the arms at the wrists and above the elbows and at the knees/lower thighs, as well as the entire trunk-the multiple straps tie to the ED bed frame);
-Staff administered Haldol 5 milligrams (mg) intramuscularly at 2:40 PM (considered to be a chemical restraint) in addition to the FBN restraint;

During an interview and observation on 06/21/11 at 3:05 PM, the ED Supervisor, Staff A stated the FBN had been used in the ED since at least 08/2010, typically on patients with suicidal ideations, those on drugs and alcohol. Staff A stated soft wrist restraints were available for use, but not kept in the ED.

Staff A demonstrated the application of the FBN:

-The patient's arms go through openings of the cloth netting material;
-The patient is positioned in the face up position;
-The arms are then restrained by velcro straps attached to the Full Body Net at the wrist and above the elbow;
-Then, approximately five long heavy cloth straps, positioned about every eight to ten inches down the body (attached to the FBN) are tied to the ED bed frame;
-The patient's entire mobilization (with the exception of the head) is limited to a few inches;
-The FBN is a fairly heavy device, weighing approximately five or more pounds.

Review of a description of the restraint on the devices' website stated the following:

-Helps control combative patients;
-For patients assessed to be in extreme danger of injury to themselves or others;
-Padded cuffs at upper arms, wrists and ankles hold limbs in place;
-Head, arms, and feet are exposed while the remainder of the body is covered by durable nylon mesh;
-Cross-straps attached to net secure to bedspring frame.

During an interview on 06/22/11 at 9:38 AM, the Chief Nursing Officer, Staff B, stated the ED staff should assess skin, in its entirety, at intervals when a restraint is applied. Staff B stated there was no policy specific to the FBN.

During an interview on 06/24/11 at 9:22 AM, ED physician, Staff Y stated he/she did not recall doing a complete skin assessment on patient #15 on admission, or thereafter. Staff Y stated the FBN was ordered in lieu of wrist restraints as it was really safe. Staff Y did not remember the removal of the FBN during the patient's ED stay. Staff Y admitted he/she did not renew the order after the first four hours of restraint. Staff Y stated the patient calmed after the Haldol, but still tried to reach out at staff, and the first priority was to protect the staff.

During an interview on 06/24/11 at 11:15 AM, RN Staff W stated he/she cared for patient #15 from 7:00 PM through discharge. Staff W stated the patient had the FBN on when he/she arrived, and it remained on the entire time. Assessment included vital signs, and checking to see if the restraint was too tight. Staff W stated he/she did not assess the patient ' s lungs, or remove the restraint for a skin assessment. Staff W stated the patient was not resisting the FBN as he/she had received Haldol earlier. Staff W stated the restraint was left on the patient, but untied for transfer.

Review of patient #15's 24-Hour Monitoring Flow Sheet-Behavior Management Restraint Flow Sheet, dated 04/14/11, showed the patient was aggressive or violent, disoriented and irrational. The section entitled, "Less Restrictive Methods Considered or Tried and Failed," was blank. Type of restraint marked was Full Body Net. The patient was in this FBN from 2:30 PM through 11:30 PM, or nine hours. The form did not identify any complete removal of the restraint. Staff failed to document a time or date the restraint was discontinued, if it was. Staff also failed to do an assessment to determine need for continuance of the restraint, and obtain a new order for the restraint at 6:30 PM, or when the initial four hours was up.

The patient was transferred to another hospital for a geriatric psychiatric inpatient stay at 11:30 PM on 04/14/11. Review of the receiving hospital's nurses' progress notes, dated 04/15/11, the patient had multiple bruises, in varying stages of color, along the neckline, on arms, trunk, feet, ankles and knees (these bruises were in places on the body that could be directly related to the location and width of the straps, or edges of the restraint), and skin tears on the patient's elbows were discovered. The patient was coughing, and a chest X-ray showed infiltrate in the midright lung field (pneumonia).

Review of a Record of Death pertaining to the patient dated 04/15/11, showed the patient expired on that date, at 11:40 PM, at the receiving hospital.

2. Review of Patient #16's ED physician's notes dated 06/14/11, showed the following:

- Patient #16 was accompanied (handcuffed) to the ED by the local police related to the spouse's fear of possible suicidal intent;
- Patient #16 was seen by the ED physician on 06/14/11 at 6:24 PM for psychiatric evaluation;
- Patient #16 denied any suicidal ideations, anxiety or depression. The patient was alert and oriented;
- The ED physician documented the patient was mildly anxious.

Review of the ED nursing triage assessment showed the following:

- The patient did not want the handcuffs on so he/she wrestled with the police;
- The patient was cooperative but agitated;
- The patient denied any medical or mental health issues.

Review of further ED nurses' notes showed the following:

- The handcuffs were removed twice from 7:35 to 7:45 PM and the patient attempted to leave the ED;
- At 7:50 PM the patient was placed in the FBN and it remained on until the patient was transferred at 10:00 PM.

Review of the physician's order for the restraint dated 06/14/11, timed 7:45 PM, showed the FBN was ordered related to violent-self-destructive behavior.

Review of the entire medical record showed no evidence of self-destructive behavior (with exception of the attempt to leave the ED), showed no evidence of lesser restrictive devices attempted prior to the application of the FBN, showed no evidence of a comprehensive assessment to determine continued need for the FBN, and showed no evidence of a one-hour face-to-face assessment.

Based interview and record review the facility failed to use the least restrictive method to control behavioral symptoms for two of two patients reviewed (Patients #15 and #16) with restraints in the Emergency Department (ED). The facility identified two patients restrained in the ED in the prior six months (January-June, 2011). The facility census was 28.

Findings Included:

1. Review of a facility policy entitled, "Restraints, Use of," revised 09/2009, showed the following:

-All patients have the right to be free from restraints, of any form, imposed as a means of coercion, discipline, convenience or retaliation;
-The use of a restraint is a last resort when least restrictive interventions (hand mittens attempted before soft extremit restraint; 2-point soft restraint before body net; sitter or request family members to stay with patient) have been determined to be ineffective to ensure the safety of the patient, staff or others.

Review of Patient #15's ED nursing assessment showed the following:

-Patient #15 presented to the ED, via ambulance, on 04/14/11 at 2:21 PM;
-The patient had a history of combativeness and confusion related to dementia;
-The patient was uncooperative and combative per nurses' notes within the assessment.

Review of ED Physician ' s Orders showed the following:

-At 2:30 PM staff placed Patient #15 in a full body net restraint (FBN-a cloth, netting type restraint that has multiple straps and velcro restrictive areas from the neckline to the knees of the patient-this restraint restricts movement of the arms at the wrists and above the elbows and at the knees/lower thighs, as well as the entire trunk-the multiple heavy cloth straps tie to the ED bed frame);
-Staff administered Haldol (an anti-psychotic medication) five milligrams (mg) intramuscularly at 2:40 PM (considered to be a chemical restraint) in addition to the FBN restraint;

During an interview on 06/21/11 at 3:05 PM, the ED Supervisor, Staff A stated the FBN had been used in the ED since at least 08/2010, typically on patients with suicidal ideations, those on drugs and alcoholics. Staff A stated soft wrist restraints were available for use, but not kept, nor typically used in the ED.

During an interview on 06/24/11 at 9:22 AM, ED physician, Staff Y stated the FBN was ordered in lieu of wrist restraints (or a lesser restrictive method) as it was really safe. Staff Y did not remember the removal of the FBN, or use of a lesser restrictive method, during the patient's ED stay. Staff Y stated the patient calmed after the Haldol, but still tried to reach out at staff, and the first priority was to protect the staff.

During an interview on 06/24/11 at 11:15 AM, RN Staff W stated he/she cared for patient #15 from 7:00 PM through discharge. Staff W stated the patient had the FBN on when he/she arrived, and it remained on the entire time the patient was in the ED. Staff W confirmed no lesser restrictive restraint had been tried while he/she was on duty.

Review of patient #15 ' s 24-Hour Monitoring Flow Sheet-Behavior Management Restraint Flow Sheet, dated 04/14/11, showed the section entitled, "Less Restrictive Methods Considered or Tried and Failed," was blank. Type of restraint marked was Full Body Net. The patient was in this FBN from 2:30 PM through 11:30 PM, or nine hours.

The patient was transferred to another hospital at 11:30 PM on 04/14/11. Review of the receiving hospital's nurses' progress notes showed the patient had multiple bruises, in varying stages of color, along the neckline, on arms, trunk, feet, ankles and knees (these bruises were in places on the body that could be directly related to the location and width of the straps, or edges of the restraint), and skin tears on the patient ' s elbows were discovered.

2. Review of Patient #16's ED physician's notes dated 06/14/11, showed the following:

- Patient #16 was seen by the ED physician on 06/14/11 at 6:24 PM for psychiatric evaluation;
- Patient #16 denied any suicidal ideations, anxiety or depression. The patient was alert and oriented;
- The ED physician documented the patient was mildly anxious.

Review of the ED nursing triage assessment showed the following:

- The patient did not want handcuffs on so he/she wrestled with the police;
- The patient was cooperative but agitated;
- The patient denied any medical or mental health issues.

Review of further ED nurses' notes showed the following:

- The handcuffs were removed twice from 7:35 to 7:45 PM and the patient attempted to leave the ED;
- At 7:50 PM the patient was placed in the FBN and it remained on until the patient was transferred at 10:00 PM.

Review of the physician's order for the restraint dated 06/14/11, timed 7:45 PM, showed the FBN was ordered related to violent-self-destructive behavior.

Review of the entire medical record, dated06/14/11, showed no evidence of self-destructive behavior (with exception of the attempt to leave the ED), showed no evidence of lesser restrictive methods attempted prior to the application of the FBN.

Based on interview and record review the facility failed to follow their own policy regarding restraint use for management of behavioral symptoms in the Emergency Department (ED) for two of two patients reviewed (Patients #15 and #16) with restraints in the ED. The facility identified two patients restrained in the ED in the prior six months (January-June, 2011). The facility census was 28.

Findings Included:

1. Review of a facility policy entitled, "Restraints, Use of," revised 09/2009, showed the following:

-All patients have the right to be free from restraints, of any form, imposed as a means of coercion, discipline, convenience or retaliation;
-The use of a restraint is a last resort when lest restrictive interventions (hand mittens attempted before soft extremity restraint; 2-point soft restraint before body net; sitter or request family members to stay with patient) have been determined to be ineffective to ensure the safety of the patient, staff or others;
-Restraint must be discontinued at the earliest possible time;
-A restraint is a medication when it is used as a restriction to manage the patient's behavior and is not a standard treatment for the patient ' s condition;
-The patient must be seen face-to-face within one hour after initiation of the behavioral restraint to evaluate the patient ' s reaction, medical and behavioral condition, and the need to continue or terminate the restraint;
-Renew behavioral restraint orders every four hours for adults by the Registered Nurse (RN) contacting the physician and report the results of his/her most recent assessment and request the original order be renewed.

During an interview on 06/23/11 at 10:45 AM, Paramedic staff V stated his ambulance was sent to a local nursing home (NH) on 04/14/11 to pick up patient #15 and transport to the local ED.

Review of Patient #15's ED nursing assessment showed the following:

-Patient #15 presented to the ED, via ambulance, on 04/14/11 at 2:21 PM;
-The patient had a history of combativeness and confusion related to dementia, and his/her left eye was sutured shut related to a recent cornea surgery;
-The patient had not received Haldol in the NH (an anti-psychotic medication that is to be used cautiously in elderly and debilitated patients-usually used for delirium [an acute mental disorder characterized by fear, anxiety and often illusions/delusions]);
-The patient was uncooperative and combative per nurses ' notes within the assessment;

Review of ED Medication Administration Records and Physician's Orders showed the following:

-At 2:30 PM staff placed Patient #15 in a full body net restraint (FBN-a cloth, netting type restraint that has multiple straps and velcro restrictive areas from the neckline to the knees of the patient-this restraint restricts movement of the arms at the wrists and above the elbows and at the knees/lower thighs, as well as the entire trunk-the multiple straps tie to the ED bed frame);
-Staff administered Haldol five milligrams (mg) intramuscularly at 2:40 PM (considered to be a chemical restraint) in addition to the FBN restraint;

During an interview on 06/24/11 at 9:22 AM, ED physician, Staff Y, stated the FBN was ordered in lieu of wrist restraints or a lesser restrictive method. Staff Y did not remember the removal of the FBN or a lesser restrictive method used during the patient's ED stay. Staff Y admitted he/she failed to renew the restraint order after the first four hours of restraint, or at 6:30 and 10:30 PM, and failed to complete the one-hour face-to-face assessment.

During an interview on 06/24/11 at 11:15 AM, RN Staff W stated he/she cared for patient #15 from 7:00 PM through discharge. Staff W stated the patient had the FBN on when he/she arrived, and it remained on the entire time. Staff W stated no lesser restrictive method was attempted while he/she was on duty.

Review of patient #15's 24-Hour Monitoring Flow Sheet-Behavior Management Restraint Flow Sheet, dated 04/14/11, showed the section entitled, "Less Restrictive Methods Considered or Tried and Failed," was blank. Type of restraint marked was Full Body Net. The patient was in this FBN from 2:30 PM through 11:30 PM, or nine hours. The form did not identify any complete removal of the restraint. Staff failed to document a time or date the restraint was discontinued, if it was. Staff also failed to do an assessment to determine need for continuance of the restraint.

Even though requested, facility staff failed to provide the evidence of a one-hour face-to-face assessment regarding the restraint use on patient #15.

Facility staff failed to follow their own restraint policy as it related to skin assessment, care planning, least restrictive devices, renewing orders, completing the one-hour face-to-face assessment, and use of two restraints at one time (chemical and physical).

2. Review of Patient #16's ED physician's notes dated 06/14/11, showed the following:

- Patient #16 was seen by the ED physician on 06/14/11 at 6:24 PM for psychiatric evaluation;
- Patient #16 denied any suicidal ideations, anxiety or depression. The patient was alert and oriented;
- The ED physician documented the patient was mildly anxious.

Review of the ED nursing triage assessment showed the following:

- The patient did not want handcuffs on so he/she wrestled with the police;
- The patient was cooperative but agitated;
- The patient denied any medical or mental health issues.

Review of further ED nurses' notes showed the following:

- The handcuffs were removed twice from 7:35 to 7:45 PM and the patient attempted to leave the ED;
- At 7:50 PM the patient was placed in the FBN and it remained on until the patient was transferred at 10:00 PM.

Review of the physician's order for the restraint dated 06/14/11, timed 7:45 PM, showed the FBN was ordered related to violent-self-destructive behavior.

Review of the entire medical record showed no evidence of self-destructive behavior (with exception of the attempt to leave the ED), showed no evidence of lesser restrictive devices attempted prior to the application of the FBN, showed no evidence of a comprehensive assessment to determine continued need for the FBN, and showed no evidence of a one-hour face-to-face assessment.

Based on interview and record review the facility failed to renew an order for restraints after an initial four-hour period of restraint on one of two patients (Patient #15) reviewed with restraints for management of behavioral symptoms in the Emergency Department (ED). The facility identified two patients restrained in the prior six months (January-June, 2011). The facility census was 28.

Findings Included:

1. Review of a facility policy entitled, "Restraints, Use of," revised 09/2009, showed the following:

-Renew behavioral restraint orders every four hours for adults by the Registered Nurse (RN) contacting the physician and report the results of his/her most recent assessment and request the original order be renewed.

Review of ED Physician's Orders showed the following:

-On 04/14/11 at 2:30 PM staff placed Patient #15 in a full body net restraint (FBN-a cloth, netting type restraint that has multiple straps and velcro restrictive areas from the neckline to the knees of the patient-this restraint restricts movement of the arms at the wrists and above the elbows and at the knees/lower thighs, as well as the entire trunk-the multiple straps tie to the ED bed frame).

During an interview on 06/24/11 at 9:22 AM, ED physician, Staff Y stated the FBN was ordered in lieu of wrist restraints as it was really safe. Staff Y admitted he/she did not renew the restraint order after the first four hours of restraint.

During an interview on 06/24/11 at 11:15 AM, RN Staff W stated he/she cared for patient #15 from 7:00 PM through discharge. Staff W stated the patient had the FBN on when he/she arrived, and it remained on the entire time.

Review of patient #15's 24-Hour Monitoring Flow Sheet-Behavior Management Restraint Flow Sheet, dated 04/14/11, showed the patient was in this FBN from 2:30 PM through 11:30 PM, or nine hours. The form did not identify any complete removal of the restraint. Staff failed to obtain a new order for the restraint at 6:30 PM, or when the initial four hours was up, and again at 10:30 PM.

Based on interview and record review the facility failed to complete a one-hour face-to-face evaluation related to use of restraints for two of two patients (Patients #15 and #16) reviewed with restraints for management of behavioral symptoms in the Emergency Department (ED). The facility identified two patients restrained in the prior six months (January-June, 2011). The facility census was 28.

Findings Included:

1. Review of a facility policy entitled, "Restraints, Use of," revised 09/2009, showed the following:

-All patients have the right to be free from restraints, of any form, imposed as a means of coercion, discipline, convenience or retaliation;
-The patient must be seen face-to-face within one hour after initiation of the behavioral restraint to evaluate the patient ' s reaction, medical and behavioral condition, and the need to continue or terminate the restraint;

Review of Patient #15's ED nursing assessment showed the following:

-Patient #15 presented to the ED, via ambulance, on 04/14/11 at 2:21 PM;
-The patient had a history of combativeness and confusion related to dementia;
-The patient was uncooperative and combative per nurses' notes within the assessment;
-The nursing assessment did not address the components of a one-hour face-to-face assessment.

Review of ED Physician's Orders showed the following:

-On 04/14/11 at 2:30 PM staff placed Patient #15 in a full body net restraint (FBN-a cloth, netting type restraint that has multiple straps and velcro restrictive areas from the neckline to the knees of the patient-this restraint restricts movement of the arms at the wrists and above the elbows and at the knees/lower thighs, as well as the entire trunk-the multiple straps tie to the ED bed frame);
-Staff administered Haldol (an anti-psychotic medication) five milligrams (mg) intramuscularly at 2:40 PM (considered to be a chemical restraint) in addition to the FBN restraint;

During an interview on 06/22/11 at 3:55 PM, Assistant Administrator, Staff H stated Physician Y included the one-hour face-to-face assessment in the physician's ED initial assessment, otherwise there was no specific one-hour face-to-face assessment in the record.

During an interview on 06/24/11 at 9:22 AM, ED physician, Staff Y confirmed he/she failed to complete a comprehensive one-hour face-to-face assessment to determine necessity to continue the restraint, as the initial ED assessment did not include the patient's reaction to the restraint, or the ongoing need to continue the restraint.

2. Review of Patient #16's ED physician's notes dated 06/14/11, showed the following:

- Patient #16 was accompanied (handcuffed) to the ED by the local police related to the spouse's fear of possible suicidal intent;
- Patient #16 was seen by the ED physician on 06/14/11 at 6:24 PM;
- Patient #16 denied any suicidal ideations, anxiety or depression. The patient was alert and oriented;
- The ED physician documented the patient was mildly anxious.

Review of the ED nursing triage assessment showed the following:

- The patient did not want the handcuffs on so he/she wrestled with the police;
- The patient was cooperative but agitated;
- The patient denied any medical or mental health issues;

Review of further ED nurses' notes showed the following:

- The handcuffs were removed twice from 7:35 to 7:45 PM and the patient attempted to leave the ED;
- At 7:50 PM the patient was placed in the FBN and it remained on until the patient was transferred at 10:00 PM.

Review of the physician's order for the restraint dated 06/14/11, timed 7:45 PM, showed the FBN was ordered related to violent-self-destructive behavior.

Review of the entire medical record, dated 06/14/11, showed no evidence of a one-hour face-to-face assessment by the Registered Nurse or physician. This was confirmed by Information Technology, Staff F.

Even though requested, staff failed to provide documented evidence of a one-hour face-to-face assessment regarding restraint use on patient #16.