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Based on staff interview, review of patient rights information, and hospital policy, the hospital failed to ensure the notice of rights provided to all patients was complete. Provision of incomplete notice of patient rights information had the potential to interfere with the ability of patients to exercise their rights. Findings include:

1. Patient rights information from the admission packet, "Your Rights as A Patient" was reviewed. It included the following information related to rights as it related to restraints:

Your right as a patient is "to be free from any form of restraint or seclusion unless needed to improve well-being and when less restrictive interventions are determined to be ineffective."

This information did not make clear each patient's right to be free from restraint or seclusion, of any form, which may be imposed as a means of coercion, discipline, convenience, or retaliation by staff and may only be used to ensure the immediate physical safety of the patient, a staff member, or others.

The Regulatory Accreditation Coordinator was interviewed on 10/13/16 at 1:00 PM. She confirmed the language in the patient rights information was not consistent with the language in hospital policy and regulatory description of patient rights related to restraints.

The hospital did not inform each patient, or when appropriate, the patient's representative of the patient's rights as they related to restraints.

2. The policy, "Visitation," dated 2/19/16, was reviewed. The policy addressed the patient's right to be informed. It included examples of clinical limitations to patient visitation rights. Examples include:

- "The patient/support person is informed of his/her visitation rights, including any clinical restriction or limitation on such rights."
- "Visitors must not have known exposure to any communicable diseases (Respiratory Syncytial Virus (RSV), influenza, chickenpox, measles, TB, etc.)..."
- "Visitors must not have a fever or symptoms of an acute illness such as upper respiratory infection or gastroenteritis.
- "Visitors must not have any visible signs of infection such as conjunctivitis, infected or draining skin lesions or herpes lesions which have not crusted over."
- Additional general visiting guidelines were included in policy, with additional restrictions.

The admission packet was reviewed. It included "Your Rights as a Patient," dated 9/2014. It addressed visitation rights. The only stated limitation: "Visitation may be limited based upon your condition."

The Regulatory Accreditation Coordinator was interviewed on 10/13/16 at 10:30 AM. She stated the hospital did not routinely provide information to patients related to visitation restrictions. Rather, she stated, they provided specific information to certain populations of patients, such as patients who were on isolation precautions, patients with a traumatic brain injury, cardiac surgery, or patients in ICU.

The hospital did not ensure all patients/support persons were informed of visitation rights as they related to any clinical restrictions or limitations.

Based on staff interview, review of complaint/grievance documentation, and hospital policy, the hospital failed to ensure an effective grievance process was in place. This resulted in misclassification of grievances as complaints for 5 of 7 patients (#7, #8, #9, #11, and #12) whose complaint documentation was reviewed. It also resulted in incomplete investigations and resolutions for 3 of 13 patients (#1, #3, and #7) whose complaint/grievance documentation was reviewed. Misclassification of grievances as complaints resulted in a failure to follow-up with complainants in writing. A failure to fully investigate grievances had the potential to result in missed opportunities for process improvements. Findings include:

The policy, "CONCERN AND GRIEVANCE PROGRAM," dated 2/2015, was reviewed. It included the following information:

- "The hospital's governing body is responsible for the effective operation of the grievance process, which includes the hospital's compliance with all the CMS grievance process requirements."
- "The Saint Alphonsus Regional Health Ministries (RHMs) Board of Directors has delegated ultimate responsibility for grievances arising out of this process to the Mission Integration Department, in collaboration with Patient Care Services, Risk Management and the Privacy Officer (when applicable)."
- "Complaints are patient issues that can be resolved promptly or within 24 hours and involve staff who are present (e.g., nursing, administration, patient advocates) at the time of the complaint. Complaints typically involve minor issues such as room housekeeping or food preferences that do not require investigation or peer-review processes."
- "A grievance is any formal or informal, written or verbal problem or concern that is communicated to the hospital by a patient or the patient's representative that has not been resolved to the satisfaction of the complainant at the time of the complaint by the staff present."
- "Any complaint that alleges a violation of a COP will automatically rise to the level of a grievance (i.e., allegations of physical, financial, and mental abuse committed by an employee or member of the medical staff.)"

The hospital's policy did not fully explain grievances. Omissions in the policy included:

- "If a patient care complaint cannot be resolved at the time of the complaint by staff present, is postponed for later resolution, is referred to other staff for later resolution, requires investigation, and/or requires further actions for resolution, then the complaint is a grievance for the purposes of these requirements."
- "Whenever the patient or the patient's representative requests that his or her complaint be handled as a formal complaint or grievance or when the patient requests a response from the hospital, the complaint is considered a grievance and all the requirements apply."

1. Grievances were misclassified as complaints. Examples include:

a. A complaint was received by telephone on 5/02/16, by a family member on behalf of Patient #11, a 75 year old inpatient, related to care during Patient #11's hospitalization on 4/13/16. There were multiple allegations related to attitude, courtesy, care, treatment, communication, coordination, and discharge. The complaint file included documentation of follow-up investigation on 5/04/16, 5/05/16, 5/09/16, and 5/10/16. On 5/11/16, the complaint file documented "case closed" and "able to resolve while patient is still here." This was not treated as a grievance until a written complaint was received on 6/16/16 from the same family member.

The "complaint" received on 5/02/16, met the definition of a grievance because it involved a complaint regarding Patient #11's care which was not resolved at the time of the complaint by staff present.

The Manager of Patient Relations and the Director of Service Excellence were interviewed together on 10/12/16, beginning at approximately 2:00 PM. They explained the complaint was not classified as a grievance because it was resolved during the hospitalization, they felt it was handled in "real time."

b. A complaint was received by telephone on 5/05/16, by a family member on behalf of Patient #12, a 59 year old inpatient. Grievance documentation stated the family member wished to file a "formal complaint." There were multiple allegations related to a lack of appropriate patient care and discharge, as well as concerns around attitude, communication, coordination, and responsiveness to requests. There was documentation of investigation on 5/05/16 and 5/06/16. A second telephone call was received on 6/28/16, by the complainant stating she had expected a letter of response. The documentation stated she was told they did not plan to write her a letter.

The "complaint" met the definition of a grievance because the complainant requested that it be treated in a formal manner.

The Manager of Patient Relations and the Director of Service Excellence were interviewed together on 10/12/16, beginning at approximately 2:00 PM. They acknowledged the complaint should have been classified as a grievance because of the request to handle the complaint in a formal manner.

c. A complaint was received by telephone on 6/20/16, by Patient #8 regarding an ED visit on 1/23/16. She stated she wanted to "file a grievance." The complainant alleged abuse and over sedation during the ED visit on 1/23/16. Initially, Patient #8 had filed a complaint, for this same visit to the ED, on 1/25/16. Neither complaint was classified as a grievance.

The "complaint" met the definition of a grievance because the complainant alleged abuse and because she requested to file a grievance.

The Manager of Patient Relations and the Director of Service Excellence were interviewed together on 10/12/16, beginning at approximately 2:00 PM. They acknowledged the complaint should have been classified as a grievance due to the allegation of abuse. They stated it was primarily handled by staff in the Behavioral Health Unit as she was a psychiatric patient.

d. A complaint was received in person on 5/07/16, by Patient #7, a 50 year old inpatient. He alleged breaches in infection control practice by a physician during his procedure. The complaint included additional allegations related to quality of care and communication. As an attempt at resolution, Patient #7 was told they would change providers.

The "complaint" met the definition of a grievance because the complainant alleged a violation in standards of infection control, which is covered under the CMS Condition of Participation of Infection Control.

The Manager of Patient Relations was interviewed on 10/12/16 at 2:45 PM. She confirmed the grievance was classified as a complaint. She stated it was felt the complaint was resolved in "real time" since they changed providers.

e. A complaint was received in person on 5/17/16 by Patient #9, a 55 year old inpatient. She alleged abuse and sexual assault.

The "complaint" met the definition of a grievance because the complainant alleged abuse.

The Manager of Patient Relations and the Director of Service Excellence were interviewed together on 10/12/16 beginning at approximately 2:00 PM. They acknowledged the allegations of abuse should have been classified as grievances.

The Director of Risk Management was interviewed on 10/13/16 at 11:48 AM. He stated he personally investigated the allegations. While it appeared at first Patient #9 had alleged sexual assault at the hospital, upon clarification, it was determined she was referencing a history of sexual assault. Multiple staff, the patient, and family members were interviewed.

2. Complaints and grievances were not adequately investigated. Without investigation, the hospital could not determine if interventions needed to be taken to prevent similar incidents with other patients. Examples include:

a. Patient #7 (referenced above) alleged breaches in infection control practice. There was no documentation of investigation of this allegation.

The Manager of Patient Relations and the Director of Service Excellence were interviewed together on 10/12/16, beginning at approximately 2:00 PM. They confirmed there was no evidence that Patient #7's allegations of breaches of infection control practices were investigated.

b. A complaint was received via "internal memo" on 5/19/16, by Patient #3, a 41 year old out-patient. She alleged she developed a systemic staphylococcus infection and blood clots as a result of placement of a PICC line on 11/23/15, at the hospital. There was no documentation the allegation was investigated. The focus of the investigation was on billing coding.

The Manager of Patient Relations and the Director of Service Excellence were interviewed together on 10/12/16, beginning at approximately 2:00 PM. They confirmed the complaint was treated as a billing issue. They also confirmed there was no documentation of an investigation regarding Patient #3's allegations of a staphylococcus infection and blood clots as a result of the PICC line.

c. A family member on behalf of Patient #1, an 87 year old inpatient, filed a grievance in person on 9/02/16. There were multiple documented allegations. One of the complaints alleged nursing staff applied a gait belt so tightly that it ruptured the patient's hernia, causing internal bleeding leading to his current condition. There was no documentation which indicated the specific allegation was investigated.

The Manager of Patient Relations and the Director of Service Excellence were interviewed together on 10/12/16, beginning at approximately 2:00 PM. They confirmed there was no evidence that Patient #1's allegations of injury, due to a nurse using a gait belt, was investigated.

3. Refer to A-123 as it relates to the failure of the hospital to ensure written notice was provided to patients that communicated the steps taken on their behalf to investigate the grievance, the results of the grievance process, and the date of completion.

The hospital did not maintain an effective grievance process.

Based on staff interview, review of patient rights information, and hospital policy, the hospital failed to establish a clearly explained procedure for the submission of patients' written grievances to the hospital. This impacted all patients and had the potential to interfere with the exercise of rights to file a written grievance. Findings include:

The hospital policy, "CONCERN AND GRIEVANCE PROGRAM," revised 2/2015, was reviewed. It did not include information on how patients could file a written complaint/grievance with the hospital, either while receiving care, or after discharge.

The admission packet with patient rights information was reviewed. It included "Your Rights as a Patient," dated 9/2014. The packet provided a telephone number for how to file a grievance with the hospital. It did not provide an address or instructions on how to file a written complaint with the hospital, either while receiving care, or after discharge.

The Manager of Patient Relations was interviewed on 10/12/16 beginning at approximately 2:00 PM. She confirmed the written information to the patients did not communicate how to file a written grievance with the hospital. She stated they used "Voice," a program where complainants could call in their complaints or concerns.

The hospital did not establish a clearly explained procedure for the submission of patients' written grievances to the hospital.

Based on staff interview, review of hospital policy, and patient rights information, the hospital failed to ensure patients were informed of a time frame for review and response to grievances. This impacted all patients and had the potential to interfere with understanding of the grievance process. Findings include:

1. The hospital policy, "CONCERN AND GRIEVANCE PROGRAM," revised 2/2015, was reviewed. It included the following time frames for review and response.

- "Every effort will be made to resolve complaints within a 24-hour period or less for any inpatient located in any department of the organization."

The hospital's definition expands beyond that which is allowed in regulatory language. Complaints are resolved by staff present at the time of the complaint or who can quickly be at the patient's location (i.e. nursing, administration, nursing supervisors, patient advocates, etc.) to resolve the patient's complaint. The definition does not allow 24 hours.

- "If the review of the concern requires a more detailed investigation - the patient/family will be advised as to the need for additional time and an expected time for completion of the review will be identified and communicated to the patient/family. The intent of this policy would be to resolve concerns for inpatients and close such concerns out (particularly on complex complaints and grievances) no later than within a 10-day process."

It was not clear as to whether the 10-day process was an extension of the complaint investigation or a grievance investigation.

- "Within 7 days of receiving the grievance notification, the complainant and/or family, as appropriate, will be sent a written communication."

It was not clear whether the 7 day time frame was to acknowledge receipt of the complaint or if it was intended to be a letter of resolution.

- "If the investigation cannot be completed by the time frame specified in the acknowledgement letter, the complainant and/or family will be contacted and provided with an expected completion date."

Patient rights information was reviewed. It did not include a time frame for review and response to grievances.

The Manager of Patient Relations was interviewed on 10/12/16 beginning at approximately 2:00 PM. She stated they tried to respond to grievances within 30 days and they tried to respond to complaints of inpatients as soon as possible and at least during the hospitalization. She stated they communicated a time frame for review in the acknowledgement letter, which was sent within 7 days. She confirmed the patient rights information provided to patients did not address a time frame for review and response to grievances.

The thirty day time frame described by the Manager of Patient Relations was not included in the policy or in patient rights information.

The grievance process did not specify clear time frames for review of the grievance and the provision of a response. Time frames for review and response were not communicated to patients in the patient rights information.

Based on staff interview, review of grievance documentation, and hospital policy, the hospital failed to ensure written notice was provided or written notice included all required information for 9 of 9 patients (#1, #2, #3, #4, #5, #7, #9, #11, and #12) whose completed grievances were reviewed. This resulted in an incomplete grievance process and had the potential to interfere with patients/complainants understanding of the steps taken to investigate and resolve their grievances and whether the investigation was considered by the hospital as closed. Findings include:

The hospital policy, "CONCERN AND GRIEVANCE PROGRAM," dated 2/2015, was reviewed. It included the following information:

"When the investigation is complete, the complainant will be sent a written communication; unless the complainant specifically states they do not want a written response [such requests should be documented]. Within limits of legal protections afforded to healthcare organizations, the written response will include:

a. Notice of the hospital's decision
b. A summary of the grievance
c. Name of the hospital contact person
d. The steps taken to investigate the grievance
e. The results of the investigation
f. The date of completion of the grievance process

Findings and actions of the investigation, along with any communication with the complainant, will be documented [in voice so the efforts can be appropriately tracked and clearly understood by all parties involved]."

This policy was not followed. Letters were incomplete or not sent. Examples include:

1. A family member on behalf of Patient #1, an 87 year old inpatient, filed a grievance in person on 9/02/16. There were multiple documented allegations. One of the allegations included: "States that had the nursing staff not applied the gait belt [sic]so tightly then the patient's hernia wouldn't have ruptured causing internal bleeding leading to his current condition." There was no documentation to indicate the specific allegation was investigated. There was documentation of verbal contact with Patient #1 and family representatives by staff during the hospitalization (9/07/16 and 9/09/16) and on 9/12/16 after Patient #1 died (on 9/10/16). There was no documentation a letter of response was sent to the complainant.

The Manager of Patient Relations was interviewed on 10/12/16 beginning at 2:00 PM. She acknowledged a written response was not provided on behalf of Patient #1 because the grievance was classified as a complaint.

2. A family member, on behalf of Patient #11 a 75 year old inpatient, filed a complaint via telephone on 5/02/16, related to care received during a hospitalization on 4/13/16. There were multiple allegations related to attitude, courtesy, care, treatment, communication, coordination, and discharge. The complaint file included documentation of follow-up investigation on 5/04/16, 5/05/16, 5/09/16, and 5/10/16. On 5/11/16, the complaint documented "case closed" and "able to resolve while patient is still here." Although the complaint qualified as a grievance, there was no letter of response to this telephone complaint. It was not until a formal written letter of complaint was received on 6/16/16, by the complainant, that it was treated as a grievance with a written letter of response on 6/24/16.

The Manager of Patient Relations was interviewed on 10/12/16 beginning at 2:00 PM. She acknowledged a written response was not provided on behalf of Patient #11 because the grievance was classified as a complaint.

3. A family member, on behalf of Patient #12 a 59 year old inpatient, filed a "formal complaint" on 5/05/16, via telephone related to care received on 5/03/16. The complaint alleged a lack of appropriate patient care and discharge. It also included concerns around attitude, communication, coordination, and responsiveness to requests. There was documentation of investigation on 5/05/16 and 5/06/16. The complainant contacted the hospital again by telephone call on 6/28/16. She stated she had expected a letter of response. She was told they did not plan to write a letter. There was no letter of response provided to the complainant regarding the grievance.

The Manager of Patient Relations was interviewed on 10/12/16, beginning at 2:00 PM. She acknowledged a written response was not provided on behalf of Patient #12 because the grievance was classified as a complaint.

4. Patient #7, a 50 year old inpatient, filed a complaint in person on 5/07/16. He alleged breaches in infection control practice by a physician during a procedure he had undergone on 5/03/16. The complaint included additional allegations related to quality of care and communication issues. There was no documentation the alleged breaches in infection control were investigated. Patient #7 was not sent a letter of response to the complaint/grievance.

The Manager of Patient Relations was interviewed on 10/12/16, beginning at 2:00 PM. She acknowledged a written response was not provided on behalf of Patient #7 because the grievance was classified as a complaint.

5. Patient #3, a 41 year old out-patient, filed a complaint via "internal memo" on 5/19/16. She alleged she developed a systemic staphylococcus infection and blood clots as a result of placement of a PICC line, on 11/23/15, at the hospital. She also disputed charges. The letter of response, dated 7/13/16, addressed the billing issues. They did not address the allegation the procedure caused her infection and blood clots.

The Manager of Patient Relations was interviewed on 10/12/16, beginning at 2:00 PM. She acknowledged the letter of response to Patient #3 did not address all the allegations documented in the complaint and was focused on billing issues.

6. Patient #9, a 55 year old inpatient, filed a complaint in person on 5/17/16, alleging abuse and sexual assault. The complaint was investigated. A written response was not provided to Patient #9 addressing the investigation and resolution.

The Manager of Patient Relations was interviewed on 10/12/16 beginning at 2:00 PM. She acknowledged a written response was not provided on behalf of Patient #9 because the grievance was classified as a complaint.

7. Patient #8, a 52 year old inpatient, filed a complaint by telephone on 6/20/16 regarding an ED visit on 1/23/16. She stated she wanted to "file a grievance." The complainant alleged abuse and oversedation during the ED visit on 1/23/16. Initially, Patient #8 had filed a complaint, for the same ED visit, on 1/25/16. Neither complaint was classified as a grievance. Neither complaint was acknowledged in writing or sent a letter of resolution.

A note, dated 1/29/16, by the Patient Relations Manager stated the following:

"Worked closely with BHU [Behavioral Health Unit] mgmt [management] to help address needs as they arose. Very difficult situation due to mental health status. Clinical opinion was that a letter would not be of assistance and potentially aggravate the situation more. All needs addressed as best as possible given acute mental illness. Pt not being d/c [discharged]."

The grievance policy did not address special circumstances, approved by the medical staff and governing body, allowing the hospital to opt out of sending letters of response to psychiatric patients.

There was no documentation Patient #8 was presented with a letter of response, in person, prior to discharge from the BHU or after her discharge.

The Manager of Patient Relations was interviewed on 10/12/16, beginning at 2:00 PM. She acknowledged a written response was not provided to Patient #8 because the grievance was classified as a complaint. She also stated, in reference to Patient #8, the BHU staff recommended not providing a written response.

9. The grievance letters sent to Patients #2, #3, #4, #5, #9, and #11 did not include a completion date of the grievance process.

The Manager of Patient Relations was interviewed on 10/12/16, beginning at 2:00 PM. She stated she thought the date of the letter would suffice to communicate to the complainant the grievance process was completed and considered closed.

Based on staff interview, review of restraint policy, medical records, pharmaceutical information, and professional literature, the hospital failed to appropriately identify chemical restraints that were ordered for 2 of 2 ED patients (#14 and #15) who were physically restrained and whose records were reviewed. This resulted in a failure to implement restraint precautions and requirements and had the potential to interfere with patient safety. Findings include:

The policy, "Restraint and Seclusion," dated 9/14/16, was reviewed. It included the following information:

- "Chemical Restraint - The use of a drug or medication as a restriction to manage a patient's behavior or restrict the patient's freedom of movement and is not a standard treatment or dosage for the patient's condition."
- "Violent: Restraints used to manage the patient's violent or self-destructive behavior jeopardizing the immediate physical safety of the patient, staff or others. Restraints used to manage the patient's violent or self-destructive behavior jeopardizing the immediate physical safety of the patient, staff or others. Restraints used to manage the patient's violent or self-destructive behavior may occur in any area of the organization. This includes the manual restraint (physical holding) of a patient for any reason, including medication administration.
- The hospital "does not permit the use of Chemical Restraint."

This policy included inconsistent information. While it stated the hospital "does not permit the use of chemical restraint," it also stated violent restraints used to manage the patient's violent or self-destructive behavior included medication administration.

Information provided by a hospital pharmacist from the Lexicomp Online program was reviewed, related to "Haloperidol." It included the following information:

- Pharmacologic Category: First Generation (Typical) Antipsychotic
- Label use included: psychosis, schizophrenia, and Tourette syndrome
- Off-label use included rapid tranquilization for agitation, aggression and violent behavior, 2.5 to 10 mg IM.

1. Medications ordered in the ED setting, which met the regulatory definition of chemical restraints, were not recognized by hospital staff as restraints. Examples include:

a. Patient #14 was an 86 year old male who was transferred to the ED via EMS from another hospital on 10/04/16 for evaluation of trauma to his urethra when he tried to pull out his Foley catheter. A Foley catheter was lodged in his urethra upon arrival at the ED.

The "ED Physician Note," dated 10/04/16 at 2:04 PM, described Patient #14 as "currently combative, which is normal, and is only speaking in Spanish, although EMS reports that he is able to speak English." Patient #14 was described in the ED note as:

- "General: Alert, agitated"
- "Neurological: Agitated, moving all extremities, appears confused."
- "Psychiatric: Cooperative."

Physician orders included, but were not limited to, the following:

- 10/04/16 at 2:09 PM: Haloperidol Lactate 5 mg, IV Push, Once, PRN Agitation. This order was not written as a restraint order.

- 10/04/16 at 2:21 PM: Restraint Order Non-Violent Soft Limb x 4 for 24 hours

Nursing documentation included the following:

- 10/04/16 at 2:00 PM: Application of soft limb restraints x 4 to "Maintain equipment/tubes, [sic] Protect from injury, [sic] Ensure patient safety [sic] Unable to follow instructions to maintain personal safety, [sic] Attempting to pull/discontinue equipment IV Lines, Urinary catheter [sic] Pt came from [hospital name] because he tried to pull his foley [sic]catheter out. There was blood at the meatus, and the staff was unable to get the catheter out. Pt is still trying to pull out the catheter at this time. Pt had head injury recently. Other: pt had a head injury, he does not understand alternatives, and this is his normal since the head injury"

- 10/04/16 at 2:12 PM: Administered Haloperidol 5 mg IV push

There was no documentation in Patient #14's medical record to indicate he had diagnoses (psychosis, schizophrenia, and Tourette syndrome) which supported the on-label use of Haloperidol 5 mg IV push. IM use was considered an off-label use for rapid tranquilization for agitation, aggression, and violent behavior.

The use of Haloperidol 5 mg IV push in a combative patient for rapid tranquilization to manage agitated behavior and protect the patient from self-harm constituted use of a chemical restraint.

b. Patient #15 was a 55 year old male treated in the ED on 9/03/16. He arrived at the ED in handcuffs escorted by local police. An RN "Emergency Room Progress Note," dated 9/13/16 at 1:13 PM, described Patient #15 as very angry, arguing with staff, repeatedly standing up and getting into the officer's face, demanding to "...leave this fucking place..." Patient #15 was described as "ox4" (oriented to person, place, time, and situation). The nursing note further stated family called EMS and reported Patient #15 had a syncopal episode and began acting very confused. EMS stated he appeared postictal (altered state of consciousness after a seizure). The RN note stated Patient #15 did not appear postictal at the time of her assessment. She described him as "belligerent and angry at all staff and officers."

An additional RN progress note, dated 9/13/16 at 1:15 PM, described Patient #15 as threatening and quoted him as saying "I am remembering your fucking faces, and I will come and pay you a visit - that a fucking promise."

Physician orders included, but were not limited to, the following:

- 9/13/16 at 1:19 PM: Haloperidol Lactate 5 mg IM Once STAT
- 9/13/16 at 1:19 PM: Diphenhydramine 50 mg IM Once, STAT
- 9/13/16 at 1:19 PM: Lorazepam 2 mg IM PRN, STAT, PRN Anxiety
- 9/13/16 at 1:29 PM: Restraint: Hard x 4 wrists and ankles, not to exceed 4 hours. Justification: Harmful to others

The medication orders were not written as restraint orders with all the associated restraint requirements. The indication for ordering Haloperidol Lactate and Diphenhydramine were not included in the physician's orders.

Nursing documentation included the following:

- 9/13/16 at 1:18 PM: Administration of Haloperidol 5 mg IM
- 9/13/16 at 1:18 PM: Administration of Diphenhydramine 50 mg IM
- 9/13/16 at 1:18 PM: Administration of Lorazepam 2 mg IM
- 9/13/16 at 1:34 PM: Application of hard restraints on wrists and ankles by security staff. He was described as belligerent and agitated and threatening to kill staff.

An article in the American College of Emergency Physicians journal, ACEP Now, dated 12/01/12, (accessed online on 10/19/16 at http://www.acepnow.com/article/chemical-restraint-ed/5/) stated "Haloperidol and lorazepam combination therapy for chemical restraint remains first line for use in medically undifferentiated emergency department patients."

The Haloperidol order 5 mg IM was consistent with the off-label use of Haloperidol for rapid tranquilization for agitation, aggression and violent behavior. The medications were being used to manage Patient #15's behavior. There was no documentation in Patient #15's record to indicate he was being treated for psychosis, schizophrenia, or Tourette syndrome (approved on-label uses of Haloperidol).

Patient #14 and Patient #15 did not have diagnoses which supported the on-label use of Haloperidol. The medication order for these patients did not meet the following criteria:

- The medication was not used within the pharmaceutical parameters approved by the Food and Drug Administration (FDA) and the manufacturer for the indications it is manufactured and labeled to address.

- The hospital did not provide evidence the use of the medication (including route of administration) followed national practice standards established or recognized by the medical community, or professional medical associations and organizations.

Chemical restraints were utilized in the ED on Patient #14 and Patient #15, without being recognized as chemical restraints, with all the corresponding restraint requirements.

The Regulatory Accreditation Coordinator was interviewed on 10/13/16 at 10:30 AM. She stated it was the hospital's policy not to use chemical restraints. She stated medications were used to treat agitation and not for the purpose of restraint. When asked if the hospital had evidence that the practice in the ED followed national practice standards, she stated she was not aware of any formal review or professional standards.

Chemical restraints were utilized in the ED on Patients #14 and #15 without being recognized as chemical restraints, and did not follow hospital policy or nationally recognized standards.

Refer to A-160 as it relates to the hospital policy on the use of chemical restraints.

Refer to A-160 as it relates to the medical staff's working knowledge of hospital policy related to the use of chemical restraints.