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Based on observation, interview and record review, the hospital failed to comply with the regulatory requirements for EMTALA when Patient 1 (Pt 1) was brought in by ambulance to the Emergency Department (ED) on 1/11/22 from a private MD's office on an emergent basis. Pt 1 was registered, triaged (the process to assign the degree of urgency based on signs and symptoms for which the patient was brought to the ED), had his vital signs measured and then assigned to wait in a corridor adjacent to the ED with an emergency medical technician (EMT) in attendance. A Medical Screen Examination (MSE) was initiated by Qualified Medical Personnel (QMP), Medical Doctor (MD 1); and lab tests, imaging, an EKG and medications were ordered. No nurse was assigned to provide care to Pt 1. No further evaluation or care was provided by nurses or the QMP. Approximately 2.5 hours later, Pt 1 was found pulseless and not breathing, code blue and Cardiac Pulmonary Resuscitation (CPR) were performed and not successful and Pt 1 was pronounced dead on 1/11/22 at 12:32 p.m. Pt 1 did not receive timely nurse evaluations and there was a delay in determining whether an emergency medical condition (EMC) existed. (refer to A2406)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality healthcare in a safe and responsible manner.

Based on observation, interview and record review, the hospital failed to conduct an appropriate and timely medical screening exam (MSE) for one of 15 patients, (Patient 1), when Patient (Pt) 1 was brought in by ambulance on 1/11/22 at 9:34 a.m. from a private MD's office on an emergent basis due to weakness, acute renal failure, not urinating and abnormal lab values. Upon arrival to the hospital Emergency Department (ED), Pt 1 was registered, triaged (the process to assign the degree of urgency based on signs and symptoms for which the patient was brought to the ED), had his vital signs measured and then assigned to wait in a corridor adjacent to the ED with an emergency medical technician (EMT) in attendance. A Medical Screen Examination (MSE) was initiated by Qualified Medical Personnel (QMP), Medical Doctor (MD 1); and lab tests, imaging, an EKG and medications were ordered. No nurse was assigned to provide care to Pt 1. No further evaluation or care was provided by nurses or the QMP.

These failures resulted in a delay in timely nursing evaluation, delay in completing the MSE and delay in determining whether an emergency medical condition (EMC) existed. At 11:55 a.m., approximately 2.5 hours after arrival, Pt 1 was found pulseless and not breathing by the radiology transporter who was assigned to take Pt 1 to obtain a chest Xray. A code blue was called, CPR was performed, and Pt 1 was pronounced dead on 1/11/22 at 12:32 p.m.


Findings:

During a concurrent interview and record review on 1/20/22 at 11:40 a.m., with the Patient Safety Specialist (PSS), Pt 1's clinical record for 1/11/22 was reviewed. The record indicated Pt 1, a 62 year old male with a history of colon cancer, was seen in his oncologist's (a physician specializing in the diagnosis and treatment of cancer) office on the morning of 1/11/22 for a review of lab test results. The oncologist's progress notes from Pt 1's office visit, dated 1/11/22, indicated, at 9:10 a.m., "Pt is very lethargic, pale. Wife reports patient had multiple falls. Patient on wheelchair. Patient looks incredibly frail. Looks quite pale. I explained in detail my concern to his wife. I have emphasized the need to go to Emergency ...will arrange for transport to ED ASAP." The progress notes also indicated Pt 1 had a new diagnosis of renal (kidney) failure.

Review of the Patient Care Record (PCR- a record of the prehospital care completed by the Emergency Medical Services [EMS] team) dated 1/11/22, indicated, an emergency call was made by the physician's office staff at 9:12 a.m. requesting ambulance service to take Pt 1 to the hospital's ED. The ambulance was at the physician's office at 9:15 a.m., departed at 9:26 a.m. and arrived at the hospital ED at 9:29 a.m. Pt 1 had oxygen (O2) on via nasal cannula at 4L/min. The narrative documentation indicated, " ...Pt 1 stated he is feeling really weak ...Pt is very weak and frail in appearance ...Staff called 911 due to patient being in acute renal failure and not urinating, lesions on liver, and elevated WBC [white blood cell] count leading them to believe he has an infection ...staff stated patient had cancer and had blood work done today ..." The PCR indicated the ambulance team transferred Pt 1 to another EMT at the hospital at 9:54 a.m.

Review of the ED Patient Care Timeline for 1/11/22, indicated, Pt 1 arrived at the hospital ED at 9:34 a.m., the triage process started at 9:40 a.m. and finished at 9:46 a.m. with an Emergency Severity Index (ESI- a 5-level triage scale used to determine patient acuity and resource needs) score of 3 assigned by the Triage RN (RN 1) who noted Pt's chief complaint to be "MD referral (sent in from cancer center, elevated WBCs, liver lesions, and not urinating)". The triage assessment indicated Pt 1 was weak and was a high risk for falls. O2 on at 4L/min with O2 saturation of 98%. The documentation indicated Pt 1 was 6 feet tall and weighed 93 lbs. Vital signs were, temperature 35.2° C (degrees centigrade), pulse 73 beats per min, respirations 14/min, blood pressure 118/80. At 9:48 a.m., RN 1 indicated Pt 1 was transferred to "EMS wait".

Review of the "ED Provider Notes", dated 1/11/22, indicated, MD 1 initiated the MSE at 10:12 a.m. and saw Pt 1 sometime between 10:12 a.m. and 10:25 a.m. At 10:25 a.m. MD 1 entered orders for an EKG, multiple lab tests including a blood culture, urinalysis, chest x-ray, CT of abdomen and pelvis, and intravenous (IV-in to a vein) antibiotics. The record indicated the EKG was done at 10:36 a.m. The record indicated none of MD 1's other orders were carried out until labs were drawn at 12:20, after the cardiac arrest. The record indicated, at 11:55 a.m., Pt 1 was found pulseless and not breathing. A code blue was called, and CPR was started. MD 1's notes indicated, at 12:32 p.m., the "code ended. Pt was in asystole after multiple rounds of advanced cardiovascular life support."

The PSS stated there was no nursing documentation in the record from 9:48 a.m. when Pt 1 was moved to the EMS wait area, until 11:58 a.m. when RN 3 responded to the code blue. The PSS was unable to find any documentation from the EMTs after Pt 1 was moved to the EMS wait area.

During a phone interview on 1/20/22 at 11:50 a.m., with the nursing Director of the ED (DED), the DED stated at times when the ED is especially busy, patients brought in by [ambulance company name] are triaged by the RN and those who are not in need of immediate attention, are moved after triage to the "EMS turnover" hallway adjacent to the ED. The EMS team that brings the patient in the ambulance to the hospital, hands off the patient to a basic life support (BLS) EMTs ("BLS turnover crew") in the hallway. The DED stated the EMTs in the EMS hallway are employees of the ambulance service. The DED stated the patients will stay there on an ambulance gurney until a nurse takes over the care which varies as far as time frame. The DED stated this arrangement applies only to patients of this ambulance service. The DED stated there is no documentation in Pt 1's record by the EMT in the hallway because the BLS turnover staff do not complete any documentation. The DED stated she was not aware that MD1's orders had not yet been carried out at the time Pt 1 was found unresponsive. The DED stated she does not have a copy of an agreement between the hospital and the ambulance company. The DED stated as far as who has responsibility for the patients in the EMS turnover area, the EMS staff or the hospital, the DED stated, "that's always been kind of a gray area."

During an interview on 1/20/22 at 12:40 p.m., with the Patient Transporter (PT), PT stated on 1/11/22 at approximately 11:50 a.m. he went to the EMS turnover hallway to check on the status of the patients with orders for radiology tests. PT stated there were four patients on gurneys in the hallway and two EMTs sat together at the end of the line of gurneys. Pt 1 was on the gurney located furthest from the EMTs. PT stated he asked an EMT if Pt 1 could get up to a wheelchair and the EMT said he didn't know but PT could check. PT stated Pt 1 was lying on his back on the gurney and had a blanket covering his head, so his face was not visible. Pt 1's lower arm was uncovered with his name band visible, so PT looked at the band and said Pt 1's name but Pt 1 did not respond. PT stated he then pulled the blanket down to uncover Pt 1's face. PT stated Pt 1's eyes were completely open and unmoving, and his skin color was gray. PT stated it was obvious he was dead. PT stated he called a code, the EMT started CPR and other staff came, and PT stated he returned to his department.

During concurrent observation, interview, and record review on 1/20/22 at 1:15 p.m., with the interim manager of ED (MED), the EMS turnover hallway was observed. The hallway was outside of ED near the radiology department. There was a sign posted on the wall identifying the hallway as the EMS turnover area. There were four gurneys lined up against the wall and two EMTs sat nearby. MED stated there were no patients in the turnover area at this time. MED stated she was working the day of 1/11/22 and was notified when Pt 1 coded. The MED confirmed that no nurse was assigned to Pt 1 during the time he was in the EMS turnover area; MED stated a nurse is not assigned to any of the patients in the EMS turnover areas. The MED stated after being assigned an ESI by the triage nurse, the [name of ambulance company] patients are put in this hallway and the EMTs "watch" them until a nurse takes over care and the patient is moved to another area. MED stated a patient could stay in the EMS turnover hallway for many hours before the patient is moved, and a nurse assumes care. The MED verified the EMTs do not document on the patient's chart. MED referred to a document titled BLS TURNOVER. The document indicated, when patients have been triaged and are turned over to the BLS EMT, the hospital may perform, " ... Lab draws, EKG, Re-triage ...physician assessment ...orders may not be given to the EMTs unless orders are given by a Base Hospital Physician and are within an EMT's scope of practice ..." MED stated this hospital is not a Base Hospital; their sister hospital across town is. MED does not have the names of the EMTs that were on 1/11/22; the EMTs are not hospital staff, and she doesn't have their names or schedule. When asked who has legal responsibility for patients in the EMS turnover hallway, MED stated, "Well technically since they have not been turned over to us, they are not our patients yet."

During an interview on 1/21/22 at 1:45 p.m. with the VP, Patient Safety, Risk Management, Regulatory & Medical Affairs (VP) 1, and the corporate Chief Nursing Officer (CNO 1), VP 1 stated she now knows the death of Pt.1 should have been reported to the office of CDPH as a potential violation of EMTALA regulations. VP 1 stated the patient (Pt 1) was on the hospital property, in the hospital hallway adjacent to the ED, had been assessed by the triage RN (hospital staff), and tests had been ordered, so this patient was the responsibility of the hospital. VP stated the agreement the hospital had with the ambulance company created a violation of EMTALA. VP 1 stated, "our nurse assigned the ESI, so they (patients in the EMS turnover hallway) are our patients." VP 1 stated as of 1/20/22 at 5 p.m. the practice of having EMTs "watch" patients has been stopped and will not occur again.

CNO 1 stated the arrangement with the ambulance company to have ambulance EMTs stationed in the hospital was initially intended to provide temporary medical oversight for patients who came in by ambulance until their staff [hospital employees] could take over care. CNO 1 stated he was not aware of how frequently this was occurring or how long the patients were without a nurse and felt "the time just stretched out longer because of the pandemic." CNO 1 stated patients who were being watched by EMTs in the hallway did not have a nurse assigned to their care.

During an interview on 1/24/22 at 9:30 a.m., with the Medical Director of the ED (MDED), the MDED stated she knew of the incident with Pt 1 in the EMS turnover hallway on 1/11/22. The MDED stated she was aware of the arrangement in place at that time between the hospital and the EMS staff. The MDED stated the MSE was initiated in the hallway by MD 1, however it was not completed. MDED stated the EMTs should have been more attentive to the patient in the hallway. The MDED stated the practice of having patient in the hallway with EMTs has been stopped.

During an interview on 1/24/22 at 4 p.m., with Pt 1's oncologist, (MD 3), MD 3 stated he saw Pt 1 in his office the morning of 1/11/22. MD 3 stated Pt 1 appeared weak, cachectic (physical wasting with loss of weight and muscle mass) and frail. MD 3 stated Pt 1's lab results that morning indicated acute renal failure and his white blood cell count was elevated. MD 3 stated he felt the patient needed care urgently; so much so that the patient was sent to the ED by ambulance from his office (located on the campus of the hospital, a few minutes away). He stated he had expected the patient to be worked-up, likely admitted and treated for kidney failure and sepsis. MD 3 stated he had planned to see Pt 1 in the hospital if he had been admitted.

During an interview on 1/25/22 at 9:30 a.m., with the ED Physician (MD 1), MD 1 stated he was working on 1/11/22 in the ED and saw Pt 1 sometime around 10:30 a.m. in the EMS turnover hallway. MD 1 stated it was busy and there were four patients on gurneys in the hallway at that time. MD 1 stated he was aware of an arrangement whereby the EMS staff would watch over patients in the hallway until ED nursing staff took over their care. He was not aware of how long it would be before that turnover process would take place. MD 1 stated the patient did not look well when he initiated the MSE. MD 1 stated he examined the patient and wrote orders for laboratory tests, imaging, and an EKG. MD 1 stated he moved on to care for other patients while waiting for the labs and imaging to be completed on Pt 1. MD 1 stated he was under the impression the EMS staff (EMTs) would monitor the patient for changes in condition and inform him in a timely manner. He stated he assumed this monitoring would include vital signs taken at least every hour. MD 1 stated he did not get notified that Pt 1's condition or vital signs had changed. MD 1 stated he heard a code called in the ED. A short time later MD 1 was informed the code was called for the patient he was caring for and another physician had responded. MD 1 stated he had initiated the patient's MSE, but he had not yet completed the process when Pt 1 coded.

During an interview on 1/25/22 at 10:15 a.m., with an operations director (OD) and a training manager (TM) for [name of ambulance service], the OD stated they were aware of the incident with Pt 1 on 1/11/22. The TM stated he is in the process of their internal investigation. TM stated when the EMTs work at the hospital on the BLS turnover crew they are scheduled in four-hour shifts, two at a time. TM stated if there are more than four patients in the turnover area, a second crew of two BLS EMTs will be on site. TM stated the EMTs main role is to interact with the patient, provide comfort and assist patient with repositioning, among other duties. TM stated the EMTs do not perform assessments or take vital signs as a routine. TM stated the EMTs must follow their CCEMSA (CENTRAL CALIFORNIA EMERGENCY MEDICAL SERVICES AGENCY) policies and procedures and are directed by their field supervisor; they are not under the supervision of hospital staff. TM stated the EMTs do not transport patients or carry out physician's orders for tests or treatment. TM stated the EMT will respond to an emergency within their scope of practice, such as starting chest compressions in a code blue situation. TM stated the EMTs are not allowed to document in the patient's record. The TM stated the EMTs fill out an internal log form. TM stated their schedule for 1/11/22, indicated a BLS turnover crew of two EMT's arrived at the hospital at 11:40 a.m. to replace the two off-going EMTs. TM stated when one crew replaces another, the off-going staff gives handoff report to the two EMTs coming on. TM stated per their records, this handoff was complete at 11:50 a.m. TM stated their log indicated the EMTs also received another patient around the same time who was vomiting and required their attention. The TM stated the hospital is ultimately responsible for the care of these patients in the EMS turnover area. The patient is registered and has been triaged by the ED RN. The patients in the EMS turnover area are the "hospital's patients."

During an interview on 1/25/22 at 11:00 a.m. with the Director of the Emergency Department (DED), the DED stated Emergency Medical Technicians (EMT) don't do assessments, "but I would hope they could see a change in condition." The DED explained the evolution of patient care in the EMS turnover hallway, stating, "One of the vulnerabilities we identified was that no care was being provided initially to the patients in the EMS hallway, then it progressed to where some tests were okay, like labs and imaging." The DED stated, "According to EMTALA, he was our patient. It's a common misconception [among staff] that they [the patients in the EMS hallway] aren't our patients until we sign off, but we've done a ton of education to clarify that they are our patients as soon as they arrive."

During an interview on 1/25/22 at 11:58 a.m. with the Triage Nurse (TN), TN stated she was a registered nurse and was working in the EMS triage area (where patients are brought in by ambulance) when Pt 1 arrived. TN remembered Pt 1 and stated he looked frail, "like one of our typical cancer patients." TN stated Pt 1 was alert and was talking to her. TN stated she did not get a call ahead of time from the oncologist's office. TN stated her assessment was that Pt 1 was not in need of immediate care. TN stated she did not recall if Pt 1 was being administered oxygen at the time of arrival. TN stated she got report from EMS staff. The Emergency Medical Technician (EMT) had a printout of Pt 1's laboratory report that had been done at the oncologist's office earlier that same day.TN stated the EMT said the abnormal laboratory results were the reason why Pt 1 was sent to the ED. TN stated she did not look closely at the laboratory results. TN stated her interaction with the patients lasts just a few minutes, and she does not see the patient again or follow up in any way. TN stated she does not give any report or hand off to a nurse. TN stated the EMT crew then pushed the gurney over to the EMT hallway area where they transferred care of Pt 1 to another EMT crew that was already there, stationed in the hospital. TN stated they do not staff the ED with EMT crews anymore, which is a very recent change.

During an interview on 1/25/22 at 2:15 p.m., with the Interim Manager of the Emergency Department (MED) and the Clinical Supervisor and Educator (CSED), the MED stated the EMS turnover hallway is no longer being used. MED stated patients arriving are assigned to nurses without delay now, and this was a recent change. The MED stated she had been concerned in the past that EMTs were not monitoring their patients, and she had spoken to them about this. MED stated she was aware that there was no documentation in the patients' charts while EMTs were watching the patients. The CSED stated, the patients are the responsibility of the hospital, "the person becomes our patient when they come within 250 feet of the property."

During an interview on 1/26/22 at 10:09 a.m. with CNO 1 and CNO 2, CNO 1 stated she was aware they had a process for patients arriving prior to the care being taken over, the "EMS holding area." CNO 2 stated she was aware that there was not a nurse assigned to these patients, but she was not aware that there was no documentation being done on these patients.
CNO 1 stated he was aware that no RN was assigned to these patients while they were waiting in the hallway. CNO 1 stated he was "Not really aware of how long it took for the handoff." He wasn't aware that they were being triaged by ED nurse prior to being sent to the hallway to wait. CNO 1 was unable to explain at what point a patient seeking care in the ED becomes the hospital's responsibility under EMTALA.

During a review of the hospital's policy and procedure (P&P) "Emergency Severity Index", dated 07/07/21, the P&P indicated, " ...All patients presenting to the Emergency Department will undergo an Emergency Severity Index Assessment by the triage nurse to initiate a Medical Screening Examination [MSE] and determine the timing, urgency, and appropriate location in the ED for completion of the MSE and disposition of the patient ..."

During a review of the hospital's P&P titled, "Triage-EMS," dated 8/2/21, the P&P indicated, " ...Purpose: to provide a timely response to patients presenting to the emergency department with medical and/or psychiatric complaints ...to allow prompt recognition of change in patient status ...Policy: All persons requesting treatment in the Emergency Department will be triaged by a Registered Nurse who has completed triage orientation and has documented competency ...Nursing staff will conduct an ongoing assessment of those patients awaiting placement into the treatment area ..."

During a review of the hospital's P&P titled, "Standards of Practice for Emergency Department," dated 1/10/22, the P&P indicated, " ...These standards of Practice are necessary and realistic levels of nursing process, which assure that quality care is given to each patient ...the purpose of these standards is to outline the baseline care a patient can expect to receive by the emergency department ...Procedure:...the patient will have a systematic and continuous assessment of their health status performed by a licensed nurse ...documentation in the Emergency Department Care Record will reflect assessment of the patient's status and needs ..."

During a review of the hospital's curriculum materials for "Emergency Department Triage Fundamentals, dated 2021, the document indicated, " ...Triage is the process of collecting patient information to determine patient acuity and priority of care ...RN must maintain communication with waiting patients ...maintain communication with treatment area ..."