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Based on observation of video surveillance, interviews, and record review, the facility failed to report to the Centers for Medicare and Medicaid Services (CMS) Regional Office Patient #1's death; which was associated with the use of an emergency medication/chemical restraint; in accordance with the facility's policy and regulatory requirements.


Findings included:


Review of the facility's Policy titled Restraint and Seclusion, effective 03/14 revealed Restraint defined as, "any physical or mechanical device, material, medication, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or dead freely. A restraint can be a drug or medication when it is used as a restriction to manage the patient's behavior or restrict the patient's freedom of movement and is NOT a standard treatment or dosage for the patient's condition." Further review revealed, "H. Report deaths associated with the use of seclusion or restraint as required."


The Restraint and Seclusion Policy directed the following in part, "Death Reporting Requirements: i) Hospitals must report deaths associated with the use of seclusion or restraint. The hospital must report the following information directly to the CMS Regional Office (RO) by telephone, facsimile, or electronically, as determined by the CMS RO, no later than the close of business on the next business day following knowledge of the patient's death:
a. Each death that occurs while a patient is in restraint or seclusion.
b. Each death that occurs within 24 hours after the patient has been removed from restraint or seclusion."


In addition, the policy further indicated that prior to reporting a death, where the hospital does not suspect death occurred due to restraint or seclusion to CMS, "notify the Director of Survey Management." This includes death that occurs while in restraint or seclusion, death that occurs within 24 hours after the restraint or seclusion has been removed with the exception of deaths while a patient is in only 2-point soft, non-rigid, cloth-like wrist restraints and there is no use of seclusion.


Review of Patient #1's Emergency Department (ED) Documentation dated 12/21/15 completed by Doctor B and Doctor C revealed Patient #1 was a 47 year old male who presented to the facility via Ambulance around 12/20/15 at 23:55; just before midnight due to altered mental status after being found in a halfway house room and not breathing with saturations (sats) in the 50's and unresponsive. Patient #1 had been discharged from the state psychiatric hospital earlier today and on the trip to the halfway house in another city; Patient #1 became combative. He was given medications for sedation. Reported was Ativan and Haldol. The patient was then dropped off at a hallway house. When they went to check on him he was unresponsive with sats in the 50's. Emergency Management Service (EMS) was called and he was placed on a nonrebreather with sats up to the upper 80's. Patient #1 was subsequently evaluated by ED physician, intubated, and was admitted to the hospitalist service due to an encephalopathy of unknown origin, hypoxia, and altered mental status.


Review of Patient #1's Nursing notes revealed Registered Nurse (RN) A documented on 12/21/15 at 06:32 AM that Patient (Pt.) removed both Intravenous therapy lines (IV's), Orogastric (OG) feeding tube, and Endotracheal (ET) intubation tube at this time; pt. is being aggressive. Doctor A made aware. Further review revealed at 06:53 AM, RN A documented Pt. removed catheter Foley at this time and is bleeding from meatus. Pt. is still being aggressive towards staff not letting staff approach him.


Record review of Patient #1's Physician Medication Orders (PO) revealed on 12/21/15 at 06:47 AM Physician B ordered the following emergency restraint medications to be given to Patient #1 STAT (immediately): 1.) Haloperidol (Haldol) 5 milligrams (mg) Injection, Intermuscular (IM), Once, STAT, 2.) Lorazepam (Ativan) 2mg Injection IM, and 3.) Diphenhydramine (Benadryl) 50mg Injection, IM, once.


Record review of Patient #1's Medication Administration Record (MAR) 12/21/15 revealed the following medications administered at 06:53 AM: Haloperidol 5 mg IM right thigh, Lorazepam 2mg IM right thigh, and diphenhydramine 50mg IM right thigh.


Review of Patient #1's Code Blue Sheet dated 12/21/15 revealed at 6:57 AM, Code Blue was called with Cardiopulmonary resuscitation (CPR) initiated. Further review at 07:18 AM, Patient #1 was pronounced deceased by Doctor B and C; and Code terminated.


Review of RN A's nursing notes revealed on 12/21/15 at 07:43 AM she documented that Patient #1 walked out of the Emergency Trauma Room nude, security followed and pt. continued to be aggressive and combative. 2 securities, 4 techs, 7 nurses present at the time. The Local Police Department (PD) was notified. Doctor B notified, gave verbal medication order. When Local PD arrived on scene patient was aggressive, charging towards staff, throwing punches, and kicking bodily fluids from the floor towards staff. The PD tased patient and patient fell to floor and hit his head. Pt. continued to be aggressive, medication administered as per Medical Doctor Orders. Pt. continued to be aggressive toward Local PD and was tased again. Pt. was placed on backboard and transferred to stretcher into room. Pt. placed on cardiac monitor and went into asystole; Advanced Cardiovascular Life Support (ACLS) protocol followed.

Review of the Emergency Documentation completed by Doctor B on 12/21/15 at 08:18 AM revealed Patient #1's Differential Diagnosis: included Cardiac arrest, cardiac dysrhythmia, hypoxia, medication reaction, seizure, intracranial hemorrhage, and head trauma. The Impression and Plan included Diagnosis of Cardiorespiratory arrest. The local Medical Examiner notified.

Review of the Deceased Patient Form completed by RN A on 12/21/15 revealed Physician C pronounced Patient #1's death on 12/21/15 at 07:18 AM. The Medical Examiner took Jurisdiction of Patient #1 due to the following documented: 1. The person dies an unnatural death, and 2. The body of a person is found, the cause or circumstances of death are unknown. An Autopsy was requested and signed by the Medical Examiner.

Observation on 03/18/16 at 9:30 AM of the facility's recorded video surveillance of public areas for 12/21/15 revealed the following observations, in part: at 6:45 AM; Patient #1 exits the Emergency Trauma Room naked with 4 hospital staff (nurses and techs) and 2 security officers following him and he heads towards the exit of the Ambulance Bay area. From 6:45 AM to 6:48 AM Patient #1 is in between the double doors to the Ambulance bay and there is no available video footage seen during this time. At 6:48 AM Patient #1 is seen just outside the facility on the ground and bleeding; at the Ambulance entrance door and with 3 local PD officers responding outside. There was one Police Officer holding out a taser. At 6:51 AM Patient #1 continued struggling while lying on the ground. At 6:52 AM, 2 Police Officers were observed holding down Patient #1 face down while a Male staff (Nurse B) approached him and administered medication IM. The officers were then seen backing away from Patient #1; who was no longer struggling. At 6:53-06:55 AM 4 staff were seen placing Patient #1 onto a backboard. At 6:56 AM Patient #1 was brought back into the Trauma room on a stretcher. At 6:57 AM Patient #1 is entering into the trauma room with 4 staff and 3 local Police Officers at the door. At 6:58 Doctor B is just outside the room observing. At 6:59 the crash cart was observed to be transported into the room where Patient #1 was.

During an interview on 03/17/16 at 11:00 AM with the Director of Risk Management (DRM) stated the death of Patient #1 that occurred on 12/21/15 at 07:18 AM was only reported to the facility's corporate office. The DRM stated the Medical Examiner was notified and obtained possession of Patient #1 for an autopsy and the local PD was conducting an internal affairs investigation. The DRM stated there was not an internal facility review or investigation for Patient #1's death.

During an interview on 03/17/16 at 4:50 PM with the local PD Lieutenant of Internal Affairs stated the investigation into Patient #1's death was still ongoing and included the Attorney General. The Lieutenant stated the local PD received a call for assistance from the facility's Emergency Department for Patient #1. The Lieutenant stated Patient #1 had been tased twice and held down for the Hospital staff to administer a shot of medication; which he then immediately coded following the series of events. The Lieutenant stated the results of Patient #1's autopsy had not been received.

During an interview on 03/18/16 at 9:10 AM with Doctor C stated that Patient #1's cause of death will most likely be a "multi-factual cause of death." Doctor C confirmed that Patient #1 received a medication/chemical restraint "combo of Ativan/Haldol/Benadryl" that is an acceptable national standard practice for emergency psychiatric issues to assist in controlling behavior. Doctor C stated he arrived on 12/21/15 around 7:00 AM when CPR was in progress; and he took over for Doctor B. Doctor C documented the marks observed on Patient #1's body as a result of being tased. Doctor B stated he was tased 1-2 times; and if the taser was then used as a stun-gun; it would not leave marks.

During the exit conference on 03/18/16 at 10:45 AM; and further interview with the Director or Risk Management (DRM) and Chief Executive Officer (CEO) present confirmed the death of Patient #1 that occurred on 12/21/15 at 07:18 AM after Patient #1 received an emergency medication/chemical restraint at 06:53 AM was not reported to CMS RO, and/or the Director of Survey Management for review. The DRM confirmed Patient #1 received an emergency medication/chemical restraint just before he coded and was pronounced deceased. The CEO stated the local PD came into the facility to complete an investigation by interviewing staff and the facility did not want to interfere in their investigation; which was still an ongoing investigation. The DRM stated administration talked to staff and looked at reports; and didn't feel it was related to the care provided; but from being tased by police. The DRM confirmed the cause of death is still unknown and the results of Patient #1's autopsy had not been made available.