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Tag No.: A2400
Based on facility policy review, medical staff rules and regulations, police report review, ambulance report review, record review, electronic documentation review and interview, the hospital failed to ensure all patients presenting to the hospital's emergency Department (ED) were provided an appropriate and ongoing medical screening examination (MSE) within the hospital's capabilities for 1 of 20 patients (Patient #1) in order to determine if an emergency medical condition existed
See Findings in Tag A2406.
Tag No.: A2406
Based on facility policy review, medical staff rules and regulations, police report review, ambulance report review, record review, electronic documentation review and interview, the hospital failed to ensure all patients presenting to the Emergency Department (ED) were provided an appropriate and ongoing medical screening examination (MSE), monitoring and treatment within the hospital's capabilities for 1 of 20 (Patient #1) sampled patients presenting to the ED.
The findings included:
1. Review of the facility's "EMTALA [Emergency Medical Treatment And Labor Act]" policy dated 9/26/2018 revealed, "..PURPOSE...The purpose of this policy is to set forth policies and procedures for Hospital's use in complying with the requirements of the Emergency Medical and Labor Act (EMTALA)...'Comes to the Emergency Department' For purposes of this policy, an individual is deemed to have 'come to the emergency department' if the individual ... Presents at a dedicated emergency department, and requests examination for a medical condition, or has such a request made on his or her behalf ...
A medical emergency condition manifesting itself by acute symptoms of sufficient severity (including severe pain, psychiatric disturbances and/or symptoms of substance abuse) such that the absence of immediate medical attention could reasonably be expected to result in either ... Placing the health of the individual... in serious jeopardy, or... Serious impairment to bodily functions, or ...Serious dysfunction of any bodily organ or part ...
'Medical Screening Examination' or 'MSE' means the screening process required to determine with reasonable clinical confidence whether an emergency medical condition does or does not exist ...
'To Stabilize' or 'Stabilize' or 'Stabilized' means ... With respect to an emergency medical condition, that no material deterioration of the condition is likely, within reasonable medical probability, to result from or occur during the transfer or discharge of the individual from the Hospital ...
POLICY ... If an individual comes to the Emergency Department:
...The hospital will provide an appropriate medical screening examination within the capability of the Hospital's Dedicated Emergency Department, including ancillary services routinely available, to determine whether or not an emergency condition exists; and ... The Hospital will: (a) provide to an individual who is determined to have an emergency medical condition such further medical examination and treatment as is required to stabilize the emergency medical condition, or (b) arrange for transfer of the individual to another medical facility in accordance with the procedures set forth below ... The Hospital will maintain a list of physicians from its medical staff who are on-call for duty after the medical screening examination to provide further medical examination and treatment as necessary to stabilize individuals who have been found to have an emergency medical condition ...
Medical Screening Examination...The hospital shall provide a medical screening examination to any individual who comes to the Emergency Department...The medical screening examination is the examination of the patient by the Qualified Medical Person required to determine within reasonable clinical confidence whether an emergency medical condition does or does not exist. The examination should be tailored to the patient's complaint, and depending on the presenting symptoms, the medical screening examination may represent a spectrum ranging from a simple process involving only a brief history and physical examination, to a complex process that also involves performing ancillary studies and procedures...Monitoring must continue until the individual is stabilized or appropriately admitted or transferred. The medical screening examination must be provided in a non-discriminatory manner...
Individuals Who Have an Emergency Medical Condition ... If after a medical screening examination, it is determined that an individual has an emergency medical condition, the Hospital must...Within the capability and capacity of the staff and facilities available at the Hospital (including coverage available through the Hospital's on-call roster), provide treatment necessary to stabilize the individual, at which time the individual may be discharged, or ... Admit the individual to the Hospital in order to stabilize the individual ... "
2. Review of the facility's Constant Observer Assessment, Implementation, And Discontinuation For Patients Under Harm Precautions policy dated 1/22/2020 revealed, "... PURPOSE: The purpose of this policy is to outline the process for the assessment, discontinuation and monitoring/tracking of constant observers for the patient under suicide/self-harm and harm to others precautions ... DEFINITIONS ... Competent Constant Observer' (CCO) means an individual who has successfully completed a facility-based competency assessment related to core elements required to monitor a patient under suicide/self-harm and harm to others precautions (see attachments)...One to one observation' means one CCO to one patient within line of sight, in close proximity with no physical barriers in the same room/area unless there exists a risk to the constant observer...Close observation' means one CCO to one or more patients in the same room/area...Line of sight observation' means one CCO in direct line of sight with one or more patients ... The Hospital will use a clinical assessment approach to determine clinically based assignment and implementation. The Hospital will have a process in place to monitor constant observer usage to ensure appropriate assignment and management of resources ...
PROCEDURE ... Assessment of Patient...The nurse will screen the patient's physical condition, behaviors, and emotional status to determine if constant observation of the patient is warranted to ensure patient's safety...If evidence-based screening or assessment reveals that a patient is suicidal/at risk of self-harm, Suicide Risk Assessment Policy...will be followed and a Competent Constant Observer (CCO) will be implemented immediately ... Implementation of Constant Observer (Nurse)...The nurse assigned to the patient remains responsible for the nursing care throughout the shift regardless of the presence of a CCO...Other caregivers will also continue to provide care as indicated by the patient's needs ... The nurse assigned to the patient will document relative to the continued need for CCO use per unit assessment frequency protocol...The Clinical Coordinator/Manager/House Supervisor will round at the start of each shift with the nurse on all patients with a CCO to assess process and care...The nurse will provide report to the CCO at the beginning of each shift to include but not limited to reason for constant observation, precautions, patient level of awareness, communication status, mobility, dietary restrictions, safety concerns, and status for visitors using the roles and responsibilities and handoff tools...The nurse will validate the CCO's documentation of patient observations every 4 hours on the designated flow sheet ...
Implementation of the Constant Observer (CCO)...The constant observer will document patient observations every 15 minutes on the designated flow sheet as indicated and as instructed by the nurse...The CCO will complete the Environment Patient Safety Checklist at a minimum of the beginning of every shift, with room change, and with any constant observer staffing change...Guidelines for the roles and responsibilities of the constant observer have been delineated and the nurse will provide then to the constant observer for review and signature each shift ..."
3. Review of the hospital's Medical Staff Rules and Regulations dated 7/11/2019 revealed, "...A qualified medical professional will conduct a medical screening examination of those individuals presenting to the emergency care center or Women's Center for examination and treatment to determine if an emergency medical condition exists. The following individuals are determined to be qualified to perform a medical screening examination in the ED: Physicians, Physician Assistants, Advanced Nurse Practitioners..."
4. Review of a police report dated 8/12/2021 at 7:30 PM revealed the local police department was called to Patient #1's house after the patient had taken an unknown amount of prescription pills due to a disagreement with a life partner. The police report documented Patient #1 told the Deputy she had taken approximately 80 Bupropion (Wellbutrin an anti-depressant medication) pills each pill being 150 mg (milligrams) that were prescribed for depression. Patient #1 was sweating profusely and asking the Deputies if they were mad at her for taking the pills. Patient #1 was determined to be in a mental crisis and a threat to herself and transported via ambulance to Hospital
#1 an acute care hospital.
5. Review of the Emergency Medical Services (EMS) report dated 8/12/2021 at 7:33 PM revealed EMS picked Patient #1 up from her home and transported the patient to Hospital #1. The EMS report revealed Patient #1 had taken "roughly 80 capsules of Wellbutrin" at about 7:15 PM. Vital signs were within normal limits and Patient #1 was assisted to walk to the stretcher on the front porch. An Intermittent Needle Therapy (INT) was started, vital signs were monitored, and a 12-lead EKG was performed in route to Hospital #1. The EKG showed Normal Sinus Rhythm (NSR) with no ST (part of the EKG tracing used to diagnose a heart attack) abnormalities. Patient #1 arrived at Hospital #1 on 8/12/2021 at 7:58 PM.
6. Review of the hospital's ED central log revealed Patient #1 presented into Hospital #1's ED on 8/12/2021 at 8:02 PM via ambulance with the chief complaint of Intentional Drug Overdose.
Review of the ED Physician note dated 8/12/2021 at 8:11 PM conducted by Physician #1 revealed, " ...Patient presents with worsening, OD [overdose] on Wellbutrin (x 80 pills) x 1 hour. Pt [patient] c/o [complains of] of vomiting and headache ...alert ...no acute distress ...IMPRESSION/PLAN ...Intentional Drug Overdose ...Ondasetron [can prevent nausea and vomiting] 4 mg IV [intravenous] push STAT [immediately] ...Sodium Chloride 0.9% 1,000 ml [milliliters] STAT ... EKG [electrocardiogram a test used to detect heart problems] ..." In addition Physician #1 ordered a chest x-ray, urine drug screens, a urine pregnancy test, a complete blood count, and a comprehensive metabolic panel.
A Competent Constant Observer (CCO) #1, who was an unlicensed staff member, was assigned to monitor Patient #1 beginning at 8:15 PM on 8/12/2021.
Review of ED Triage completed on 8/12/2021 at 8:45 PM by Registered Nurse (RN) #1 revealed, " ...reported taken 80 pills of Wellbutrin ...hx [history] of depression, pt c/o headache, nausea ...Pain Score: 5 [on a scale of 1 - 10 with 10 being the most severe] ..." Patient #1 was on room air and the patient's vital signs were a heart rate of 118, respiratory rate was 18, the patient's blood pressure was 124/88, and the patient's O2 saturations was 98 (O2 sat normal being 92 -100 indicates the amount of oxygen in your blood).
Review of ED Physician #1's re-examination of Patient #1 dated 8/12/2021 at 8:50 PM revealed, " ...Currently alert and oriented x 3 some mild nausea with a dull headache but otherwise stable. Currently denying suicidal ideations. I have spoken with poison control and they advised observing for at least 23 hour observation ..." A consult was ordered for the Physician #2, an ED Hospitalist, to take care of Patient #1.
On 8/12/2021 at 8:56 PM, ED Physician #1 ordered Continuous Cardiac Monitoring, Binasal Cannula Oxygen (BNC) at 2 liters (l) to keep the patient's O2 sat greater than/equal to 92% and perform routine vital signs (VS).
On 8/12/2021 at 11:52 PM the Patient's O2 sat was 97% (there was no documentation the patient's O2 sat was checked again until 8/13/2021 at 7:40 AM at which time it was 45%).
On 8/12/2021 at 8:57 PM, ED Physician #1 ordered Lorazepam (Ativan, a sedative used to treat seizures) 1 mg IV Push every (q) 4 hours as needed (PRN) seizures and Seizure Precautions. ED Physician #1 wrote as an addendum
that Patient #1's EKG showed a normal sinus rhythm with sinus tachycardia.
Review of the Medication Administration Record (MAR) revealed RN #1 administered a 1000 milliliter (ml) normal saline (NS) bolus at 9:38 PM and administered Ondasetron 4 milligrams (mgs) IV push. There was no documentation of a nursing assessment before, during or after the administration of the NS and Ondasetron.
On 8/12/2021 at 10:44 PM, ED Physician #1 ordered Patient #1 to be placed on the Outpatient-Med-Surg and at 10:47 PM and telemetry monitoring was ordered. There were no rooms available and Patient #1 remained in the hallway of the ED.
Review of the Physician Progress Notes dated 8/12/2021 at 10:51 PM conducted by Physician #2 revealed, " ...34-year-old-female ...intentionally took about 80 tablets of Wellbutrin impulsively ...Stated she regretted it immediately ...Vitals are stable ...Poison control was contact and advised the patient admitted overnight ...IV therapy started and psychiatric consult has been placed ...Plan ...IV fluids ...Consult psychiatry ...Telemetry monitoring ...Monitor hemoglobin ...Monitor creatinine levels ..." Physician #2 documented, "I anticipate discharge within the next 24 - 48 hours depending on continued clinical progress". (There was no further evidence a physician examined or evaluated Patient #1 until 8/13/2021 at 6:35 AM).
On 8/12/2021 at 11:46 PM, RN #1 administered Ondasetron 4 mg IV stat to Patient #1. There was no documentation of an assessment of the patient.
On 8/12/2021 at 11:56 PM, RN #1 documented Patient #1 was awake, alert, and oriented with a heart rate of 101, respiratory rate was 17, BP was 123/80, and the patient's O2 sat was 97.
Review of the COO's notes revealed on 8/13/2021 at 1:00 AM Patient #1 was on a stretcher in the hallway and attempting to pull at her INT needle and O2 tubing.
Review of Patient #1's MAR revealed on 8/13/2021 at 1:00 AM the patient experienced a seizure and was administered Ativan 1 mg IV push. There was no documentation of a nursing or physician assessment of the patient or the type of seizure, the length of time the patient experienced a seizure, or a post assessment of Patient #1 after the patient had experienced the seizure.
During interviews on 10/18/2021 and 10/19/2021 with the ED Director, Physician #1, Physician #2, RN #1, and RN #2 they all verified Patient #1 remained on a stretcher in the ED hallway.
Review of the Behavior/Close Observation form completed by the CCO on 8/13/2021 at 6:15 AM revealed Patient #1 was in the hallway, lying still, and began mumbling incoherently. According to the instructions on the form, CCO staff were to immediately notify nurses if this behavior was observed. There was no documentation in the medical record the nurse was notified of Patient #1 mumbling incoherently.
Review of the Behavior/Close Observation form on 8/13/2021 at 6:30 AM revealed Patient #1 was in the hallway, mumbling incoherently, and began getting out of bed without notifying staff. According to the instructions on the form, CCO staff are to immediately notify nurse if this behavior was observed. There was no documentation in the medical record the nurse was notified of Patient #1 getting out of bed without notifying staff.
Review of the Behavior/Close Observations form revealed no documentation the ED nurses validated the CCO's observations every 4 hours in accordance with facility policy.
On 8/13/2021 at 4:39 AM, ED Physician #4 ordered for Patient #1 to receive Ativan 2 mg IV Push and the medication was administered by RN #1. There was no documentation in the medical record for the indication for the Lorazepam. There was no documentation the nurse or physician had assessed Patient #1 prior, during or after the Ativan administration.
Review of the Physician Progress Notes dated 8/13/2021 at 6:35 AM conducted by Physician #2 revealed, " ...Seen, no adverse events as per RN, no complaints this am ...Review of Systems ...unable to obtain due to encephalopathy ...Impression...Acute metabolic encephalopathy secondary to medication effect ...Patient may not be able to protect airway may need to be intubated..."
Review of Patient #1's vital signs dated 8/13/2021 at 7:40 AM revealed RN #2 documented the patient's heart rate was 118, respirations were 10, the BP was 132/85 and O2 the patient O2 sat had dropped to a dangerously low 45%.
Review of a late entry ED nursing note dated 8/13/2021 at 8:45 AM revealed RN #2 documented, "... 0742 pt in hall bed, witnessed seizing. O2 [oxygen] placed 6L [liters] bnc [binasal cannula], jaw thrust maneuver performed. sats dropped to 35% during postical [postictal] ... 0745 pt remains postictal/unresponsive ... O2 15 L via NRB [Non Re-breather] placed to pt, O2 sat increased to 60%. Prepping trauma room for pt and subsequent intubation ... MD aware; RT [Respiratory Therapy] aware ...0748 moved to T1 [(ED)Trauma Room #1], placed on cardiac monitor. crash cart to bedside, zoll pads placed. sats remain in 60s-70s with 15L NRB. manual ventilation initiated ... via Ambu bag to face mask. RT at bedside prepping for intubation. Sats increased to 80% with bag mask ... 0802 + [positive] full body seizure activity lasting appx [approximately] 10 seconds ... 0810 full body seizure lasting appx 7 seconds ...0812 + full body seizure activity last appx 45 seconds ... 0814 [Name of Physician #3] MD at HOB [head of bed]; etomide [hypnotic drug to induce anesthesia] 20 mg IVP and succinylcholine [medication for short term paralysis and anesthesia] 80 mg IVP administered ... 0815 Successful intubation ... 0825 sats increased to 95% ... vent settings: tidal volume 450, PEEP 10, rate 20, 100% O2 ..."
Review of the physician's note dated 8/13/2021 for 7:57 AM revealed Physician #3 documented Patient #1 "...was held in the ED overnight and progressively worsened throughout the morning with episodes of seizing, per nursing staff. Patient became unresponsive and moved to T1 [trauma room #1] for intubation and critical monitoring..."
Review of the EKG performed on 8/13/2021 at 8:30 AM revealed Patient #1 was in sinus rhythm with occasional premature ventricular contractions, possible atrial enlargement, Right Bundle Branch Block and cannot rule out inferior infarct [heart attack].
On 8/13/2021 at 8:45 AM, Physician #3 ordered Patient #1 to be transferred to the Intensive Care Unit after intubation and respiratory arrest. Patient #1 was admitted to ICU on 8/13/2021 at 12: 18 PM.
During Patient #1's hospitalization, the patient was diagnosed with Sepsis secondary to Aspiration Pneumonia, progressed to renal failure and was on Continuous Renal Replacement Therapy, a tracheostomy was placed on 8/27/2021, and her last EEG showed severe encephalopathy.
On 9/13/2021 at 2:04 PM, Patient #1's family elected hospice services and the patient was removed from the ventilator.
Patient #1 passed away on 9/13/2021 at 3:15 PM.
7. In an interview on 10/18/2021 at 1:29 PM,CCO #2 confirmed she was the CCO for Patient #1 on 8/13/2021 between 5:00 AM and 7:45 AM. CCO #2 stated they did 1:1 observations and sat in front of the patient's stretcher. CCO #2 stated around 6:15 AM the patient began mumbling incoherently and 6:30 AM the patient was trying to get out of bed. CCO #2 stated she notified the nurse when the patient began mumbling.
In an interview on 10/18/2021 at 2:10 PM, Physician #2 verified he was the hospitalist working overnight and saw Patient #1 in the ED. Physician #2 stated at approximately 10:47 PM Patient #1 was "obtunded" but alert. Physician #2 stated Patient #1 became more obtunded overnight and remained in the ED as overflow transition due to no available beds. Physician #2 stated he was not notified of Patient #1's seizures, but should have been. Physician #2 stated regarding the 8/13/2021 at 6:30 AM note, the patient was becoming much more obtunded and had oxygen via mask.
In an interview on 10/18/2021 at 2:10 PM, the Director of Quality verified the hospital did not have a Seizure Policy. The Director stated the Physician was responsible for what they want done when they order seizure precautions.
In an interview on 10/19/2021 at 7:05 AM, RN #2 verified she was working in the ED overnight and saw Patient #1 in the ED. RN #2 stated Patient #1 was in the first bed by the charge nurse desk, had a sitter, a cardiac monitor, 02 sat monitor and a Dinamap (designed to monitor blood pressure, temperature, and pulse oximetry). RN #2 verified she was aware seizures were a risk factor for a patient with a Wellbutrin overdose. RN #2 stated she took the Ativan for the 8/12/2021 1:00 AM dose from the drug cart and gave the Ativan to RN#1 who administered the Ativan to Patient #1.
When asked to describe what Patient #1's seizure looked like, RN #2 stated, "...she started grinding her teeth and making animal like sounds...she stiffened and her arms turned outward across the bedrails..." RN #2 did not recall the movement of Patient #1's lower extremities during the 1:00 AM seizure.
When asked what were the hospital's seizure precautions when a physician ordered seizure precautions and RN #1 stated, "...Monitor cardiac, pulse ox, pad the side rails..."
During a telephone interview on 10/19/2021 at 8:00 AM, Physician #1 verified he was the on-call physician working 3:00 PM - 1:00 AM on 8/12/2021 - 8/13/2021 and saw Patient #1 in the DED. Physician #1 stated the patient took a "bunch" of Wellbutrin in a moment of anger.
When asked about the seizures for Patient #1, Physician #1 stated the seizures started about 8:00 AM.
When asked about the Hospitalist role, Physician #1 stated the Patient was admitted to the Hospitalist but sometimes, especially at night it may be difficult to reach them. If the patient was still in the ED, the ED physician is available if something happens.
During an a telephone interview on 10/19/2021 at 8:45 AM, Physician #3 verified he was the on-call physician working 6:00 AM - 11:00 AM on 8/13/2021 and saw Patient #1 in the DED. Physician #3 stated some of the concerns with Wellbutrin overdose include seizures and heart abnormalities. Physician #3 stated at shift change, he saw and heard Patient #1 agitated and acting out. Physician #3 stated he did not think she was hypoxic at the time but in a couple of hours she deteriorated. Physician #3 stated Patient #1 was in "the middle of traffic" in the ED and for 10 hours she was stable. Physician #3 stated staff responded appropriately when she declined. Physician #3 stated, for the amount of Wellbutrin the patient ingested, it "takes hours for the effects to be seen."
During an interview on 10/19/2021 at 9:00 AM, RN #1 verified she worked as an RN/Charge Nurse in the ED and saw Patient #1. RN #1 stated Patient #1 came in by ambulance after a drug ingestion of Wellbutrin and suicidal ideations. RN #1 stated Patient #1 was placed on a cardiac monitor, a dinamap at all times, was stable, then she had a seizure, the doctor ordered Ativan, they continued to monitor her, she had another seizure, continued to monitor, and then RN #1 left the hospital at 6:00 AM.
When asked how frequently vital signs should be taken in the ED, RN #1 stated she didn't know if there was a policy, just takes as needed.
When asked which nurse was assigned to Patient #1 from the time of admission until the next shift, RN #1 stated, "Mainly me. I was the charge nurse."
RN #1 further stated they keep seizure patients in line of sight of the nurse and stated she "assumed responsibility of her in the hallway ...right in front of me ..."
RN #1 stated Patient #1 relaxed and went to sleep after she administered both doses of Lorazepam.
When asked if she should have documented Patient #1's seizure activity, response to medication, and condition during her shift, RN #2 stated, "If I would have had time that night I would."
In a telephone interview on 10/19/2021 at 10:35 AM, Physician #4 verified he was an on-call physician working in the ED and stated the ED had been busy especially at night with patients being held in the ED.
When asked if he remembered Patient #1, Physician #4 stated he did not.
When asked about the ordered Ativan for Patient #1 on 8/12/2021 at 4:39 AM, Physician #4 stated if he saw a patient in the ED having a seizure or a nurse told him a patient was having a seizure, he would give an order. Physician #4 stated it was almost impossible sometimes at night to reach a Hospitalist, especially for the nurses on the floor. When asked if the physician should make a note about the seizure and the medication, Physician #4 stated, " ...if it had been my patient, I would have written a note ..."
In an interview on 10/19/2021 at 10:50 AM, the ED Director stated the ED consisted of 34 beds including 6 fast tract and 8 chest pains beds. Nursing staff worked 12 hour shifts with generally 5 starting at 7:00, 11:00, and 3:00 and continuing. The charge nurse was in the staffing pattern but arrived an hour earlier. The ED Director stated he tried to have at least one EMS/paramedic on duty each shift as well.
When asked how often the nurses are expected to document vital signs in the ED, the Director stated during the Initial Assessment and then based on acuity.
When asked if the ED had gone on diversion, the Director stated, " ...We don't go on diversion. We have gone on critical adviser when other ERs [ED] have ..."
When asked if he expected the nursing staff to document seizure activity, the ED Director stated, "Yes ...do the best we can with all the holding ...we have finite resources ...I expect the staff to follow all process."
In an interview on 10/19/2021 at 2:58 PM, the Director of Quality verified there was no training documentation for CCO #1 or #2 to provide constant observation for Patient #1.
In a follow-up telephone interview on 10/19/2021 at 3:46 PM, Physician #1 was asked what he had expected when he wrote an order for Seizure Precautions and Physician #1 stated to keep the head of the bed elevated to keep the patient from aspirating, pay attention to the patient in case of a seizure, have oxygen available, raise the side rails so they don't roll off the bed, and order as needed Ativan if they do have a seizure.
When asked if he would expect to be notified if his patient had a seizure Physician #1 stated, "Yes, you want to be in control of the seizures at the time."
When informed Physician #4 gave the order for Ativan for a second seizure for Patient #1, Physician #1 stated, " ...you move on after they are admitted ..."
When asked if Patient #1 had an Emergency Medical Condition, Physician #1 stated, "Yes ...was stable ...warranted watching another 24 hours ..."
The hospital failed to provide an ongoing MSE of Patient #1 while in the hospital's ED. Patient #1 experienced two separate seizures which required Ativan administration and there was no documentation either a physician or nurse assessed the patient. There was no documentation of the type of seizure precautions implemented to protect Patient #1 and to prevent deterioration of her health status. The hospital failed to monitor and assess Patient #1's O2 saturations and ensure seizure precautions were implemented for Patient #1 in order to avoid worsening or declining health.