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.

INDIANA REGIONAL MEDICAL CENTER 835 HOSPITAL ROAD INDIANA, PA 15701 Jan. 9, 2015
VIOLATION: PATIENT RIGHTS Tag No: A0115
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on review of facility documents, medical records (MR), and staff interviews (EMP),
it was determined the facility failed to follow adopted policies, by administering medication that the patient was refusing (A 0131), for one of one patients (PT1), by ensuring that the patient received care in a safe setting (A 0144) for one of one medical records reviewed (MR1), failed to ensure that the use of restraints was in accordance with a written modification to the patient's plan of care (A 0166), for four of four applicable emergency department medical records reviewed (MR1, MR7, MR8, MR9), failed to ensure that restraints were implemented in accordance with safe and appropriate restraint techniques (A 0167), for one of one patients (PT1), failed to ensure the use of restraint was in accordance with the order of a physician or other licensed independent practitioner (A 0168), for two of four applicable emergency department medical records reviewed (MR1, MR7), and failed to ensure that when restraint was used for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others, that a face-to-face evaluation conducted within one hour after the initiation of the intervention was documented as described in the facility's adopted policy (A 0178), for three of three applicable emergency medical records reviewed. (MR1, MR7, MR8)

Findings include:

Review of the facility's policy entitled "Use of a Restraining Device and/or Seclusion for the Violent & Self-Destructive Patient", dated February 2013, was completed. The policy stated "... Purpose: To provide guidelines for the emergency use of a restraining device and/or seclusion in response to an unanticipated outburst of severely aggressive or destructive behavior while protecting and preserving the patient's safety, dignity, rights and well-being. Philosophy: Indiana Regional Medical Center is committed to preventing, reducing and striving to eliminate restraint and seclusion and to preventing emergencies that have the potential to lead to using restraint and seclusion, and strives to limit the use of restraining devices and/or seclusion in the delivery of care to those situations with appropriate and adequate clinical justification. Nonphysical intervention is preferred, and the least restrictive restraining device and/or seclusion, that meets the patient's assessed need, will always be used and will be discontinued as soon as possible. The use of a restraining device and/or seclusion for staff convenience, as a means of coercion, retaliation, or discipline is prohibited. Patient Rights: Every patient has the right to be free from all forms of restraint and/or seclusion unless necessary for medical management. Condition for Use of Restraint or Seclusion: Can only be used to: ... To ensure the immediate physical safety of the patient, a staff member or others; When less restrictive interventions have been determined to be ineffective to protect the patient, a staff member or others from harm; When it is the least restrictive intervention that will be effective to protect the patient, a staff member or others from harm ... Definitions: Restraint for Violent and Self-Destructive Management: Any device that limits mobility or temporarily immobilizes a patient that is applied in an emergency situation in response to an unanticipated outburst of severely aggressive or destructive behavior that poses an immediate danger of the patient harming themselves or others. Physical Restraint: Any manual method, physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body or head freely ... Chemical Restraint: A drug or medication used as a restriction to manage the patients (sic) behavior or restrict the patient's freedom of movement and is not a standard treatment or dosage for the patient's condition ... Exceptions: This policy does not apply to: ... Other Methods that involve the physical holding of a patient for the purpose of conducting routine physical examinations or tests ... Assessment: During the assessment process the patient and/or family are to be informed of Indiana Regional Medical Center's philosophy to be restraint and seclusion free. Restraint or seclusion will only be used when there are no other alternatives and maybe used to ensure the patient's immediate physical safety even if the patient is not violent or self-destructive ... Alternatives: Alternatives refer to identifying, developing, and promoting innovative preventive strategies to reduce/eliminate the use of restraint and/or seclusion. Less restrictive alternatives are always preferred and are to be attempted before using a restraint and/or seclusion. Alternatives may include, but are not limited to: 1:1 interaction ... Position Change ... Relieve pain & discomfort ... De-escalation or Diversional Activity ... Offer nutrition & fluids ... Redirection or Reorientation to surroundings ... Ambulation/exercise/toileting ... Ask family/friends to stay with patient ... Modify environment ... Explain procedures ... Relaxation techniques. Initiation: The decision to use a restraint and/or seclusion must consider the patient's age, physical and psychological status and be driven by an assessment of the patient's needs, not by diagnosis, restraint and seclusion history, or solely on a history of dangerous behavior. 1. A physician's order is required for the use of a restraint and/or seclusion. 2. In the absence of a physician, a qualified RN may initiate emergency use of restraint and/or seclusion in response to a patient who is posing an immediate danger to themselves/others and alternatives are not viable. 3. Immediately after initiating a restraint and/or seclusion, the RN: Must notify the physician and obtain an order for the restraint and/or seclusion ... Consults with the physician about the patient's physical and psychological status ... Notifies and educates the patient/family with consent about the clinical reason for using a restraint and/or seclusion and the criteria for discontinuation ... Must contact the attending physician as soon as possible if the attending did not order the restraint or seclusion. 4. A Physician, Physician Assistant or specially trained RN (Unit Manager or Shift Coordinator), in accordance with new requirements, is required to see the patient face-to-face, within 1 hour from the time the intervention is initiated. 5. If the patient is released from the restraint and/or seclusion before the physician arrives, the physician must still perform the face-to-face assessment within the 1-hour time frame. 6. If the physician ordering the restraint and/or seclusion is not the attending physician, the attending physician must be contacted as soon as possible. 7. The physician: Reviews with the staff the patient's physical and psychological status; Makes necessary revisions to the plan of care, including determining whether restraint or seclusion should be continued; and Provides the staff with guidance to identify ways to help the patient regain control so that the patient meets the criteria for discontinuation; and Supplies an order, or if necessary, a new order. 8. Documentation must include: A description of patient's behavior and the intervention used; 1-hour face to face medical and behavioral evaluation if restraint and seclusion is used to manage violent or self-destructive behavior; Alternatives or other less restrictive interventions attempted (as applicable); The patient's condition or symptom (s) that warranted the use of the restraint or seclusion; The patient's response to the intervention (s), including the rationale for the continued use of the intervention ... Notification of the patient's family, when appropriate A time limited written order; Criteria for discontinuation and evidence the patient was informed of the criteria; Any injuries sustained by the patient and treatment rendered; and A revised plan of care to reflect the use of restrain and/or seclusion. Physician Education: Physicians will be educated on key elements of this policy and use of restraints on orientation and at each reappointment cycle. Staff Education: Education and competency validation for clinical staff will occur at orientation and subsequently, on a periodic basis and include: The impact of restraint on patient rights, dignity and specific needs of patient population ... Techniques to identify staff and patient behaviors, events and environmental factors that may trigger needs to use restraint or seclusion ... Use of non physical intervention skills ... Choosing the least restrictive intervention based on the individualized patient assessment ... Safe application and removal of restraints, recognizing signs or physical and psychological distress ... Clinical indications that restraints or seclusion are no longer necessary ... Monitoring physical and psychological well-being of patient (e.g. respiratory and circulatory status, skin integrity, vital signs, elimination, nutrition needs), and ... First aid and CPR ... In addition to the above requirements, competency for RN's who are authorized to initiate and discontinue restraint and/or seclusion, and to reassess the patient every 15 minutes include: Recognizing how age, developmental considerations, gender issues, ethnicity, and history of sexual or physical abuse may affect how a patient reacts to physical contact and when to contact a medically trained LIP or emergency medical services to evaluate and/or treat a patient's physical status; Taking vital signs and recognizing the significance of any changes; Assessing and meeting the patient's nutritional and hydration needs; Assessing circulation, sensation and motion in the extremities; Assessing and meeting the patient's hygiene and elimination needs; Assessing the patient's physical and psychological status; Using behavior criteria for discontinuing restraint and/or seclusion; Assessing the patient in meeting the criteria for discontinuation; Assessing the readiness and assisting the patients in meeting behavior criteria for discontinuation of restraint and/or seclusion; and Assessment/reassessment of the patient and documentation. Application or removal of restraint and the initiation or discontinuation of seclusion: A qualified RN must supervise the application and removal of a restraint and the placement or removal of a patient in seclusion ... Only qualified staff may apply or remove a restraint ... Only qualified staff may place a patient in or remove a patient from seclusion ... Orders: 1. Standing orders, PRN orders and restraint protocols are prohibited. 2. Orders are to include: Assessment that clinically justifies the need for restraint and/or seclusion; Type of restraint and/or seclusion to be used; Date and start time for restraint and/or seclusion; Duration of restraint and/or seclusion use; and Criteria for discontinuation. 3. Restraint and/or seclusion orders cannot exceed: 4 hours for patients [AGE] and older ... 2 hours for children and adolescents ages 9 and 17 ... 1 hour for children under 9 ... The plan of care must reflect the loop of assessment, intervention, evaluation, and re-intervention ... Assessment, Intervention, Evaluation, and Re-Intervention: 1. The RN assesses and documents the patient's response to alternatives, at the initiation and discontinuation of restraint and/or seclusion, and every 15 minutes during the episode. 2. 15 minute reassessments include,a s appropriate for the restraint and/or seclusion in use: the need for continued restraint and/or seclusion; physical and psychological status and comfort; circulation, sensation, movement, skin integrity and ROM in the extremities; nutrition/hydration; temperature, pulse, respirations and blood pressure; readiness for discontinuation; hygiene and elimination; signs of any injury associated with applying restraints or seclusion; 3. A patient requiring simultaneous restraint and seclusion is continually monitored (face to face) 1:1 by an assigned, trained staff member or continually monitored in close proximity by trained staff using both video and audio equipment ... Restraint and Seclusion Log: Because the use of restraining devices and/or seclusion involves risk, monitoring their use is part of Indiana Regional Medical Center's Performance Improvement Plan. Aggregate data is reviewed to identify patterns and trends and when opportunities for the improvement are identified action plans will be developed and implemented by the individual department and/or terms ... Procedure: A. Soft Limb Restraint. 1. Place the restraint under the limb with the Velcro opening toward you. 2. Wrap the restraint around the limb and secure with the Velcro tag. 3. Wrap the tie around the limb and secure the quick clip. 4. Secure to the frame using a slip knot ... Documentation: A. Physician's Orders 1. Type: Select the type of restraint and/or seclusion to be used. 2. Clinical Justification-High risk of injury to self or others. 3. Initial Start time: Enter the time and date the restraint and/or seclusion episode is initiated. 4. Criteria for Discontinuation: Check all that apply. 5. The date and time the order is obtained, physician signature, and RN's signature if the order is a verbal/phone order. 6. The face-to face assessment is where the physician, physician assistant or specially trained RN assessment is documented to include the time the assessment occurs and the signature of the individual completing the assessment ... B. Patient Assessment: 1. Clinical Assessment: Each area is completed by placing a check mark in the applicable box. 2. Behavior: Check all that apply. 3. As evidenced by: Complete using a few words describing the reason identified in #2, signed, dated and timed by the RN or physician completing the assessment. 4. Alternatives Attempted: Check all alternatives attempted. In an emergent situation when alternatives are not viable, check this box. 5. Patient/Family Education: The RN providing the patient/family education checks all applicable boxes. Restraint and/or Seclusion Monitor for Behavioral Management (flow-sheet) 1. Date: Enter today's date. 2. Time: Each shift has a separate page with the time in 15-minute increments. 3. Discontinuation Criteria: Check if the discontinuation criteria is met or not met. 4. Q 15 min.: Reassessment completed by RN, who enters his/her initials in the corresponding box. 5. Need for Continued Restraint and/or Seclusion: Every 2 hours the RN writes a narrative assessment note indicating: the need for continued restraint and/or seclusion, release criteria met restraint/seclusion discontinued. The RN's brief reassessment should be in the form of brief descriptive terms. 6. Staff Signature and Initials: Every staff member documenting on this form is to sign their name in the space provided followed by their initials. Documentation Related to Chemical Restraint: 1. The Patient Assessment section of the Order Sheet and Assessment Record for Chemical/Physical Restraint and/or Seclusion is completed as described previously. 2. A physician's order for chemical restraint is written in the Physician's Orders section of the Order Sheet and Assessment Record for Chemical/Physical Restraint and/or Seclusion. 3. To avoid a standing or PRN order, this can only be a one-time single dose order. 4. The order is transcribed per hospital policy. 4. After the medication ordered as a chemical restraint is administered, the MAR is documented per hospital policy for medication administration. 6. The RN's narrative note documents the patient's response to receiving a chemical restraint. 7. The RN's assessment of the patient and the effectiveness of the chemical restraint is also documented in a narrative note. 8. The Restraint and Seclusion Reassessment Sheet is initiated and completed until the RN's reassessment indicates the patient is no longer influenced by the chemical restraint."

Review of the policy entitled "Use of Restraints in the Non-Violent Non-Self Destructive Patient", dated May 2014, was completed. The policy stated "... Purpose: To provide guidelines for the use of a restraining device to promote medical/surgical care while protecting and preserving the patient's safety, dignity, rights and well-being ... Every patient has the right to be free from all forms of restraint unless necessary for medical management. Condition for Use of Restraint: Can only be used: To ensure the immediate physical safety of the patient, a staff member or others; When less restrictive interventions have been determined to be ineffective to protect the patient, a staff member or others from harm; In accordance with a written modification to the patient's plan of care to include the use of restraints; In accordance with safe and appropriate (least restrictive method) restraint and seclusion techniques as determined by hospital policy in accordance with state law; and Discontinuation at the earliest possible time. Definitions: Non violent and Non Self-Destructive Restraint Types. Physical Restraint: Any manual method, physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body or head freely. Chemical Restraint: A drug or medication used as a restriction to manage the patients (sic) behavior or restrict the patient's freedom of movement and is not a standard treatment or dosage for the patient's condition ... Exceptions: The policy does not apply to: ... Other Methods that involve the physical holding of a patient for the purpose of conducting routine physical examinations or tests ... Alternatives: Alternatives refer to identifying, developing, and promoting innovative preventive strategies to reduce/eliminate the use of restraint. Less restrictive alternatives are always preferred and are to be attempted before using a restraint ... A physician's order is required for the use of a restraint. If the attending physician did not order the restraint, the attending physician must be consulted, as soon as possible, but no longer than their next visit. PRN Restraint Orders are Not Acceptable ... In the absence of a physician, a R.N. may initiate emergency restraint in response to a patient who jeopardizing their medical/surgical care, and alternatives are not viable. A RN must obtain an order either during the emergency application or immediately after initiating a restraint ... Nursing Documentation Requirements: Circumstances leading to the use of restraint based on individual assessment ... Results of the alternatives attempted ... Rationale for the type of restraint used ... The patient was informed of the criteria for discontinuation, if feasible ... Revise plan of care to reflect the use of restraint ... Documentation must indicate the restraint was discontinued at the earliest possible time ... Restraints Specific for ICU Intubated Patients: ... For those patients that the physician deems at a very high risk of danger should the airway be lost, soft limb restraints will be utilized and restraint policy followed ... Physician Education: Physicians will be educated on key elements of this policy and use of restraints on orientation and at each reappointment cycle. Staff Education: Education and competency validation for clinical staff will occur at orientation and subsequently, on a periodic basis. Education and competency validation includes: The impact of restraint on patient rights, dignity and specific needs of patient population ... Techniques to identify staff and patient behaviors, events and environmental factors that may trigger needs to use restraint or seclusion ... Use of non physical intervention skills ... Choosing the least restrictive intervention based on the individualized assessment ... Safe application and removal of restraints, recognizing signs or physical and psychological distress ... Clinical indications that restraints or seclusion are no longer necessary ... Monitoring physical and psychological well-being of patient (e.g. respiratory and circulatory status, skin integrity, vital signs, elimination, nutrition), and First aid and CPR. In addition to the above requirements, the competency requirements for staff authorized to monitor patients a minimum of every one (1) hour (or more frequently as determined by the individualized plan of care) includes: Taking vital signs and recognizing the importance of reporting changes to the RN; Recognizing and meeting nutritional and hydration needs; The ability to check circulation, sensation, and motion in the extremities; Recognizing and meeting hygiene and elimination needs; Monitoring physical and psychological status; Helping the patient meet the criteria for the discontinuation of the restraint; Recognize when the patient has met the criteria for the discontinuation of the restraint; and Recognize when to contact the RN or physician to evaluate and/or treat the patient's physical condition ... Orders: 1 Standing order, PRN orders and restraint protocols are prohibited. 2 Order includes: Assessment that clinically justifies the need for restraint ... Type of restraint to be used ... Date and start time for restraint ... Duration of restraint order may not exceed one day ... Criteria for discontinuation ... Restraint Log: Because the use of restraining devices involves risk, monitoring their use is part of Indiana Regional Medical Center's Performance Improvement Plan. Aggregate data is reviewed to identify patterns and trends and when opportunities for improvement are identified action plans will be developed and implemented by the individual department and/or teams ... ."

Review of the Order Sheet and Assessment Record for Chemical/Physical Restraint or Seclusion for Violent or Self-Destructive Behaviors revealed a section entitled Physician's Orders which stated "Physician or specially trained RN/PA face to face assessment is required: - Within 1 hour initiation-8 hours for patients 18 years and older - by MD -4 hours for patients 17 years and younger - by MD" This section also included sections to be completed including, but not limited to Clinical Justification, Restraint Type, Criteria for Discontinuation. There was also a section entitled "Physician or specially trained RN/PA face to face assessment", which stated I have completed a face-to-face assessment of the patient and consulted with clinical staff involved in the patient's care. I have determined alternative interventions were unsuccessful and clinical justification exists for the use of restraint and/or seclusion." This section was noted to have a check box indicating assessment had occurred with 1 hour of initiation, and a space for the physician's signature, with date and time. In addition, there is a "Patient Assessment" section of this Order Sheet, which includes, but was not limited to Sections to be completed, including patient orientation, level of consciousness, mobility, and range of motion, a section to describe that there is a high risk for injury to the patient or others, alternatives attempted, and patient/family education and care planning.

Review of the facility's policy entitled "Patient Rights & Responsibilities", dated February 2013, revealed "I. Policy Statement. Indiana Regional Medical Center has a strong commitment to seeking, listening and responding to our patients' needs and concerns ... As a patient or a parent or legal guardian of an unemancipated child [AGE] or younger, you have the right to expect the following from our physicians and healthcare personnel ... Care in a safe setting ... To refuse any drug, treatment or procedure offered by the hospital, to the extent permitted by law, and to be informed of possible medical consequences ... ."

1) Review of MR1 revealed that the patient was requesting Xanax, and patient was made aware that request for Xanax was not possible. Documentation indicated that Geodon was ordered and the patient was adamantly refusing the medication. Documentation stated that patient was not cooperative with the order for Geodon and threatened staff stating [they] were going to fight staff. Documentation then stated that the patient was held down by two security guards and three staff members, and the Geodon was administered by intramuscular injection.

Interview with EMP8, on November 6, 2014, revealed "... [The patient] was refusing medication ... [The patient] was combative when ordered medication ... The Dr. told [the patient], [they] can't refuse the medication at this point in time ... ."

Interview with EMP13, on November 6, 2014, revealed "... I mixed the medication. I hadn't previously cared for the patient ... [The patient] wandered around the department. [The patient] was held down, [the patient] said [they] were going to fight us ... They held [the patient] down. I adminstered the IM injection ... ."

An interview with EMP10 on November 6, 2014, was conducted. EMP10 stated the patient was given Geodon and was held down for the injection. EMP10 stated that the patient fought the Geodon but it was given to deal with [their] condition, and stated that staff knew why patient came in, threatened [they were] leaving, [the patient] was out of bed walking around, patient was notified [they were] not allowed to leave, patient stated that it would take an Army to hold [them], patient stated that [they] will fight [their] way out of the hospital, patient was irritable and pacing room, and continued to threaten staff, which was why [they were] held down and given medicine.

Documentation received by EMP24 on December 4, 2014, revealed that the facility does not have a policy on forced medication.

2) Review of MR1, relative to PT1, revealed the patient presented with depression and a suicide attempt.

Review of the ambulance trip sheet, associated with PT1 revealed "... Upon making patient contact, crew found ... asleep on a hospital bed ... ."

Review of MR2 (receiving hospital), relative to PT1, revealed "Patient arrived on unit ... Patient was wrapped in two blankets. One blanket was tied in a double knot around patients chest restricting arm movement. The other was tied behind patients (sic) back in a double knot under [their] scrubs restricting movement ... Patient asleep upon arrival ... ."

A telephone interview with EMP9, on November 6, 2014, at 2:45 PM, revealed "... The blanket was tied around [the patient] like a cape ... ."

An interview with EMP8 on November 6, 2014, at 12:20 PM, revealed "... [The patient] had a blanket on ... tied ... like a cape over [their] shoulders. That was [their] way of wearing the blanket. It was a defiance type of thing ... ."

A telephone interview with EMP5 on November 7, 2014, at 11:25AM, revealed, regarding the blanket, " ... [The patient] had been sitting on the bed, it was wrapped around [their] waist like a bath towel kind of thing ... ."

3 ) Review of MR1 revealed documentation that the patient was held down with two security guards and three staff members for the administration of medication. There was no documentation in the record that the use of a physical hold was utilized in accordance with a written modification to the patient's plan of care.

Review of MR7 revealed documentation that the patient was placed in a physical hold by police and security, in order for a straight catheterization for urine to be obtained. There was no documentation in the record that the use of physical hold was utilized in accordance with a written modification to the patient's plan of care.

Review of MR8 revealed documentation that the patient was placed in four point leather restraints. There was no documentation in the record that the use of restraints was utilized with a written modification to the patient's plan of care.

Review of MR9 revealed documentation that the patient was placed in four point soft limb restraints. There was no documentation in the record that the use of restraints was utilized with a written modification to the patients plan of care.

4) Review of MR2, relative to PT1, revealed a note which stated "... Patient arrived on unit ... Patient was in four point soft restraints upon arrival. Restraints were placed on patient with arms crossed over chest ... ."

A telephone interview with EMP9, on November 6, 2014, at 2:45 PM, revealed "... [The patient] was sleeping, with their arms crossed ... I was in the room when we moved [the patient] from the ER stretcher to their (ambulance) stretcher ... The restraints were soft. I believe they did four points, so [the patient] wouldn't be combative with ambulance personnel going down the road. [The patient's] arms were crossed because [they were] sleeping in that position. The left wrist to the right rail and the right wrist to the left rail ... ."

Review of facility document revealed "... [EMP9] ... was in the room when restraints were applied. The patient was moved from the ER stretcher to the ambulance stretcher with ... arms crossed. [EMP9] stated ... witnessed the ... crew apply the restraints with patient's arms crossed but ... didn't realize that it was a safety issue ... ."

5) Review of MR1 revealed documentation that the patient was held down with two security guards and three staff members for the administration of medication. There was no order present on the record for the use of a physical hold.

Interview with EMP10, on November 6, 2014, revealed that they did not think there was an order for the physical hold. Continued interview with EMP10, on November 7, 2014, revealed "To me, that's not something we do ... If it's momentary, it's not a restraint."

Review of MR7 revealed documentation that the patient was placed in a physical hold by security and police, in order for a straight catheterization for urine to be obtained. There was no order present on the record for the use of a physical hold.

6) Review of MR1, revealed documentation that the patient was placed in a physical hold for the administration of forced medication. There was no documentation that a face to face evaluation was documented per facility policy on the Order Sheet and Assessment Record for Chemical/Physical Restraint Seclusion for Violent or Self-Destructive Behaviors. The Order Sheet and Assessment Record for Chemical/Physical Restraint or Seclusion for Violent or Self-Destructive Behaviors was not present on the record.

Review of MR7 revealed documentation that the patient was placed in a physical hold by security and police, in order for a straight catheterization for urine to be obtained. There was no documentation that a face to face evaluation was documented per facility policy on the Order Sheet and Assessment Record for Chemical/Physical Restraint Seclusion for Violent or Self-Destructive Behaviors. The Order Sheet and Assessment Record for Chemical/Physical Restraint or Seclusion for Violent or Self-Destructive Behaviors was not present on the record.

Review of MR8 revealed documentation that the patient was placed in four point leather restraints. During review of the the Order Sheet and Assessment Record for Chemical/Physical Restraint or Seclusion for Violent or Self-Destructive Behaviors, it was noted that the face to face assessment section of the Sheet was not completed.
VIOLATION: PROGRAM DATA, PROGRAM ACTIVITIES Tag No: A0283
Based on review of facility documents, and staff interview (EMP), it was determined the facility failed to monitor the effectiveness and safety of their use of restraints, by failing to identify problem prone areas and to identify opportunities for improvement, as required by their adopted policies.

Findings include:

Review of the facility's "Performance Improvement Plan", dated May 2014, revealed "... Measurement & Process. Performance measurement is data driven. Data is collected from multiple sources and comparative data is reviewed and analyzed to determine needs and priorities. Sources may include: Indicators of organizational or department aspects of care which are high volume, high risk, problem prone ... ."

Review of the facility's policy entitled "Use of a Restraining Device and/or Seclusion for the Violent & Self-Destructive Patient", dated February 2013, revealed "... Purpose: To provide guidelines for the emergency use of a restraining device and/or seclusion in response to an unanticipated outburst of severely aggressive or destructive behavior while protecting and preserving the patient's safety, dignity, rights and well-being. Philosophy: Indiana Regional Medical Center is committed to preventing, reducing and striving to eliminate restraint and seclusion and to preventing emergencies that have the potential to lead to using restraint and seclusion, and strives to limit the use of restraining devices and/or seclusion in the delivery of care to those situations with appropriate and adequate clinical justification. Nonphysical intervention is preferred, and the least restrictive restraining device and/or seclusion, that meets the patient's assessed need, will always be used and will be discontinued as soon as possible ... Restraint and Seclusion Log: Because the use of restraining devices and/or seclusion involves risk, monitoring their use is part of Indiana Regional Medical Center's Performance Improvement Plan. Aggregate data is reviewed to identify patterns and trends and when opportunities for the improvement are identified action plans will be developed and implemented by the individual department and/or terms ... ."

Review of the policy entitled "Use of Restraints in the Non-Violent Non-Self Destructive Patient", dated May 2014, revealed "... Purpose: To provide guidelines for the use of a restraining device to promote medical/surgical care while protecting and preserving the patient's safety, dignity, rights and well-being ... Restraint Log: Because the use of restraining devices involves risk, monitoring their use is part of Indiana Regional Medical Center's Performance Improvement Plan. Aggregate data is reviewed to identify patterns and trends and when opportunities for improvement are identified action plans will be developed and implemented by the individual department and/or teams ... ."

1) Review of Restraint Logs dated January 1, 2014 through October 31, 2014, was completed. The Logs revealed:

January 1, 2014-February 1, 2014: Restraint Log revealed restraint use on 6B Nursing Unit, Emergency Department, Geriatric Care Center (Behavioral Health), and ICU (Intensive Care Unit).

February 1, 2014-March 1, 2014: Restraint Log revealed restraint use on 6B Nursing Unit, Geriatric Care Center, and ICU.

March 1, 2014-April 1, 2014: Restraint Log revealed restraint use on 6B Nursing Unit, Emergency Department, and ICU.

April 1, 2014-May 1, 2014: Restraint Log revealed restraint use on 6B Nursing Unit, Emergency Department, Geriatric Care Center, ICU, and 7 Telemetry Nursing Unit.

May 1, 2014-June 1, 2014: Restraint Log revealed restraint use on 6B Nursing Unit, Emergency Department, Geriatric Care Center, ICU, and 7 Telemetry Nursing Unit.

June 1, 2014-July 1, 2014: Restraint Log revealed restraint use on 6B Nursing Unit, Emergency Department, Geriatric Care Center, ICU, and 7 Telemetry Nursing Unit.

July 1, 2014-August 1, 2014: Restraint Log revealed restraint use on 6B Nursing Unit, Emergency Department, Geriatric Care Center, ICU.

August 1, 2014-September 1, 2014: Restraint Log revealed restraint use in Emergency Department, ICU, and 7 Telemetry Nursing Unit.

September 1, 2014-October 1, 2014: Restraint Log revealed restraint use on 6B Nursing Unit, Emergency Department, Geriatric Care Center, and ICU.

October 1, 2014 to October 31, 2014: Restraint Log revealed restraint use on 6B Nursing Unit, Emergency Department, Geriatric Care Center, ICU, 4 Surgical Nursing Unit, and 7 Telemetry Nursing Unit.

Review of nursing unit quality sheets provided to surveyors entitled "Restraint Data Tool" was completed. It was noted that there were no Restraint Data Tool sheets provided for the 6B Nursing Unit, Emergency Department, 7 Telemetry Nursing Unit, or for the 4 Surgical Nursing Unit. In addition, there were no Restraint Data Tool sheets provided for the Intensive Care Unit for the months of January, February, March, April, or October 2014.

2) Review of Restraint Data Tool Sheets, described by EMP14 as Quality Department Monitors, revealed that these Tools were Quality Department monitors. These Data Tools listed each Nursing Department (7 T, Peds, 6 Med, 4 Surg, ICU, RCC, OB, ED, BHS), with spaces for percentage of compliance with indicators including Clinical Justification, Type of Restraint, Time Limited, Time Initiated, Criteria for Discontinuation, MD/RN Signature/Date/Time, Assessment Completed, Documentation Alternatives, Updated Care Plan (Restraints), Flow Sheet (Date), M/S q 1 hr. checks or Behavior q 15 min. checks RN, q2 Hours, Reason that Restraints Necessary, Restraints Removed Earliest Possible Time.

Data Tool Sheets provided by facility were reviewed and revealed that between January 2014-June 2014, applicable data was not assessed for the 6B Nursing Unit, 7 Telemetry Nursing Unit, 4 Surgical Nursing Unit, Intensive Care Unit, Emergency Department.

There was no Data Tool Sheet provided for July 2014. Data Tool Sheets for August and September 2014, revealed applicable data was not assessed for 6 B Nursing Unit, 7 Telemetry, Emergency Department, Intensive Care Unit, or the 4 Surgical Nursing Unit.

3) Interview with EMP14 on November 7, 2014, revealed that the Unit Based Educators are responsible for pulling information, monitors on restraints. EMP14 stated they are "getting back on track", and these should come to the Quality Department on a periodic basis. EMP14 stated that the quality document is to be done on every unit that uses restraints.
VIOLATION: EMERGENCY SERVICES POLICIES Tag No: A1104
Based on review of facility documents, medical records (MR), and staff interviews (EMP), it was determined the facility failed to follow adopted policies related to care of the psychiatric patient for seven of nine applicable medical records reviewed. (MR1, MR4, MR6, MR7, MR13, MR14, MR15)

Findings include:

Review of the ED policy entitled "Care of the Psychiatric and Behavioral Patients in the Emergency Department", dated December 2013, revealed "Objective: To assure psychiatric and behavioral patients are managed in a safe and effective manner while ensuring their safety and the safety of IRMC patients and staff. Triage: 1. These patients will be triaged in the same manner as any other patient and prioritized as a 1 or 2 (active threat or actual harm) or 3 (verbal threat, stated intent of harm, or expression of any time psychiatric related aliment/complaint). 2. Patient exhibiting suicidal and/or homicidal ideation, attempted suicide and/or homicide or an intentional overdose will be placed directly in exam room 4, if available, or within staff/security's direct line of sight of the patient. 3. ED Charge Nurse will be notified. 4. Nursing triage assessment will be completed by triage nurse. Special Note: Any patient exhibiting suicidal and/or homicidal ideation, attempted suicide and/or homicide or an intentional overdose, shall be immediately placed under continuous 1:1 observation by a member of the emergency room staff, security, or other responsible party. Continuous observation may not be provided by a family member(s), police officer(s), etc. Continuous observation will be maintained unless discontinued by a written physician's order. Examination Room: 1. In addition to the routine ED nursing assessment and medication reconciliation, a Psychiatric nursing assessment will be completed by the registered (sic) Nurse (RN) and is completed regardless of level of consciousness, responsiveness, or medical condition. 2. A psychiatric packet is printed immediately after the psychiatric nursing assessment is completed. Special Note: If after the initial triage, the patient expresses symptomology that is psychiatric in nature, the Psychiatric nursing assessment will be completed by the RN and psychiatric packet will be printed. 3. Patient clothing and all belongings are removed from the room and secured at the nurses' station for any patient exhibiting suicidal and/or homicidal ideation, attempted suicide and/or homicide, or an intentional overdose and any other patient thought to be at risk to self/others. RN who does the nursing psychiatric assessment is responsible for removing clothing/belongings from the patient and recording this information in the medical record. 4. All secured belongings must be checked by security/designee, placed in the nurses' station, and findings will be recorded on the inventory sheet. 5. ED Physician must perform a medical screening and psychiatric assessment. Upon completion of psychiatric screening, the ED Physician is responsible to determine need for continuous 1:1 observation. 6. ED Physician must record all routine findings in the T-System and fully complete, score, and sign the psychiatric assessment form. Physician psychiatric assessment must be done regardless of patient level of consciousness, responsiveness, or medical condition. If the ED Physician is unable to complete the assessment, the reason (s) must be clearly documented on the assessment. 7. A comprehensive discharge bundle and written plan for follow-up treatment must be completed on all psychiatric patients being discharged . Special Note: If a 201 or 302 warrant is executed on any patient, the warrant must be thoroughly completed before the patient is transferred to any behavioral health unit. 1:1 Observation: 1. ED nursing staff will provide 1:1 until such time that additional support from security or other responsible party arrives. 2. The "Special Monitoring Log" must be removed from the psychiatric packet and given to the person responsible for the 1:1 observation. If not provided by the ED staff, the person doing the 1:1 will be responsible for obtaining the log. 3. The person responsible for the 1:1 observation is required to document patient behavior/activity on the "Special Monitoring Log" every 15 minutes starting from the time of arrival and will continue until 1:1 is discontinued or the patient leaves the ED. Gaps in documentation are not acceptable. 4. Staff member assigned 1:1 will be within directly view of the patient and at a distance which would allow for immediate response ... ."

1) Review of MR1 revealed an order by the physician to "Please d/c security @ 1700. At
1725 documentation stated "Pt sitting up in bed, taking off monitor ... Security present out side of room. Dr ... aware and okay with them coming back after releasing them ... There was no Special Monitoring Log 15 Minute Check Sheet present on the medical record.

Review of MR4 revealed the patient presented with suicidal ideation. Nursing documentation in the medical record indicated that security was present, and there was no physician order to discontinue security presence. During review of the medical record, it was noted that there was no Special Monitoring Log 15 Minute Check Sheet present on the record.

Review of MR6 revealed the patient presented with Depression, at approximately 20:54. During review of the medical record, a physician's order timed 21:30 was noted to state that Security not needed. There was no documentation in the medical record indicating that security was present from 20:54 to 21:30, and no Special Monitoring Log 15 Minute Check Sheet was present on the record.

Review of MR7 revealed the patient presented with Overdose at approximately 0238. Documentation in the medical record revealed "Transported to ICU with Security 1:1 and leather restraints as ordered." During review of the record, it was noted that there is no Special Monitoring Log 15 Minute Check Sheet documentation between 0238 and 0500.

Review of MR13, revealed the patient presented for suicide attempt at approximately 0212. During review of the medical record, there was no documentation to indicate that facility staff were called for 1:1 observation, and there is no Special Monitoring Log 15 Minute Check Sheet present on the record. It was also noted that there was no physician order to indicate that 1:1 Observation was not needed.

Review of MR14, revealed the patient presented for Depression, at approximately 1616, for threatening behavior, and patient had stated that they wanted to hurt a lot of people. Nursing documentation in the medical record indicated that security was at the patient's door for safety. Nursing documentation indicated that the patient left the premises at 1728. There is no Special Monitoring Log 15 Minute Check Sheet present on the record.

Review of MR15, revealed the patient presented after expressing suicidal and homicidal thoughts, at approximately 2215. Nursing documentation at that time indicated that both security and police were at the patient's bedside from 2215, until discharge 2318). There is no Special Monitoring Log 15 Minute Check Sheet present on the record.