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Tag No.: A2400
Based on review of medical records, initial assessment, autopsy report, policies and procedures, and interviews, it was determined that the facility failed to provide appropriate treatment within its capability and capacity for one of 20 sampled patients, Patient #1 (P#1), when P#1 presented to the Emergency Department on 3/4/19 for difficulty breathing.
Findings were:
Cross refer to A-2406, as it relates to the facility's failure to provide P#1 with an appropriate Medical Screening Examination.
Cross refer A-2407, as it relates to the facility's failure to provide P#1 with stabilizing treatment.
Tag No.: A2406
Based on review of medical records, initial assessment, autopsy report, policies, and interviews, the facility failed to provide an appropriate medical screening examination to assess and treat the emergency medical condition for patient (P) P#1 of a sample of 20 patients.
P#1 was not evaluated timely based on the criteria for ESI (Emergency Severity Index- emergency department triage program to assess patient acuity based on their presentation in the Emergency Department (ED) and the expected level of care the patient will require.) P#1 presented to the facility's (ED) with difficulty breathing, abnormal vital signs, heart rate of 170 beats per minute and a pain score of 10 out of 10. P#1 was documented as not breathing and without pulses upon initial assessment, and expired in the facility's ED.
Findings Include:
A review of Patient #1 's medical record documented the patient was admitted to the facility's ED on 03/04/2019 at 6:56 p.m. with complaints of diarrhea, vomiting, fever, flu, and abdominal pain. The record revealed P#1 was screaming out and hyperventilating (breaths at an abnormally rapid rate) and P#1's mother stated her daughter had been screaming since 6:00 p.m. P#1 's ED record revealed that P #1 was a nine-year-old female with a past medical history of asthma.
P#1's medical record revealed at 7:04 p.m., P#1 was triaged (assessment by a nurse to determine the priority in which patients will be seen based on their chief complaint, signs, and symptoms) by a Registered Nurse (RN) as a level 3V (3V -vertical, patients could tolerate being seated or seen in a seated position). P#1 reported her pain was a 10 on a scale of 0 -10 (0 = No pain, 10 = severe pain).
P#1's vital signs at triage were: Temperature: 98.2 Fahrenheit (Pediatric normal range was 97.5 to 98.6). Heart Rate:170 (High) (Pediatric normal range was normal 75-118) Respiratory Rate: 22 (Pediatric normal range was 18-25) Blood pressure: 106/84 (high) (Pediatric normal range was 97-115/57-76) Oxygen saturation: 100% (Pediatric normal range was 94-100%).
P#1 had no known allergies, previous medication list included oseltamivir (Tamiflu brand name, used for influenza virus), Albuterol (used by asthmatic patient), cetirizine (antibiotics), ibuprofen (pain medicine), montelukast (prevent asthma attack), positive for sickle cell trait.
Review of P#1's initial assessment by MD BB revealed P#1 was apneic (temporary cessation of breathing) and without pulses on initial assessment. CPR was immediately initiated, and P #1's pupils were assessed to be approximately 6mm, fixed, and dilated (possible sign of coma). P#1's assessment revealed P#1 had coffee ground colored (bloody) emesis (vomit) during bag-valve breaths which were subsequently suctioned. MD BB documented the respiratory department was paged and P#1 was intubated. MD BB documented P#1's heart revealed oscillation between pulselessness (absence of heart activity) and spontaneous circulation (ROSC) with no pericardial effusion (fluid back up around the heart). The physician documented P#1's time of death as 9:04 p.m. on 3/4/19.
A review of P#1's autopsy report dated 3/21/2019, revealed P#1 expired due to diffuse alveolar damage (changes that occurred to the structure of the lungs during injury or disease) and tracheitis (inflammation of the trachea/windpipe) on 3/4/19 at 9:04 p.m. The report documented P #1 was unresponsive in the Pediatric ED waiting room. The staff-initiated CPR and continued resuscitative measures until P#1 expired.
An interview was conducted with the Chief Medical Officer (CMO) on 4/27/21 at 9:15 a.m. CMO stated a triage level (3V) was appropriate for P#1 because he did not think anything was abnormal from Patient #1's vital signs. CMO explained the sequence of events related to P#1 on 03/04/2019 before P#1 expired were:
1. P#1 registered in the central log at 6:56 p.m.
2. P #1 triaged by RN FF at 7:04 p.m.
3. P #1 called to the room by RN EE, but no one responded at 7:45 p.m.
4. RN EE came back to call another Patient at 7:49 p.m., heard P #1 ' s mother saying "please help ".
5. P#1 unresponsive, brought back to ED room coded (abrupt loss of heart function, breathing and consciousness). at 7:50 p.m.
An interview was conducted with the ED Lead Nurse (RN) EE on 4/27/21 at 10:00 a.m. RN EE explained she worked the night of the incident. She stated she came out of the ED room and looked at the ED log of patients in the waiting room. RN EE said she saw P#1's heart rate on her workstation, went to the waiting room, and called P#1's name but no one responded. RN EE explained she documented on P#1's flow sheet that she had attempted to call P#1 then went back to the waiting room to call another patient. RN EE said at that moment she heard P#1's mother say, "please help me." RN EE stated she saw P#1 in a wagon, unconscious with her eyes rolled back. RN EE said she immediately took P#1 to the trauma room and a code was called. RN EE said on her workstation she could see age, chief complain, vital signs of patient waiting to be seen in the waiting room. RN EE said she would have triaged P#1 as an (ESI Level 2) and said that decision was subjective, and that she was not the triage nurse the night the incident occurred.
In an interview with the ED Director (ED) on 4/27/2021 at 10:30 a.m. the ED explained when RN EE went to the waiting room for a second time, she found P #1 unresponsive and called a code on her, unfortunately, P #1 expired. ED said when the hospital conducted an internal investigation of the incident, they determined P#1 could have been triaged as ESI level 2 but the standard of care offered to P #1 was deemed appropriate.
A review of the facility's policy number 4258 titled 'ED Triage Policy', approved 12/20/2019, last reviewed 12/20/19 revealed the purpose of the policy was to provide standards for triage activities in the adult and pediatric ED using the ESI 5-level system. Emergency Department triage at the facility was in the process of collecting pertinent patient information and initiating a decision-making process that categorized and prioritized the needs of the patients that sought care. This process was always performed by an RN.
Further review of the policy revealed that on arrival, all patients presented to the Quick Registration station, located near the Adult and/or Pediatric Triage booth. The quick registration clerk entered a minimum amount of patient information into the registration system to ensure the correct ID and to populate the patient on the ED tracking system. The Quick Registration clerk alerted the triage nurse of obvious concerns or complaints. If a patient presented with any of the following complaints, the clerk notified the triage nurse immediately:
1. Chest pain
2. Sudden onset of slurred speech, facial droop, or asymmetrical weakness in the extremities.
3. Weakness, nausea, and sweating.
4. Shortness of breath.
5. Any other concerning complaints.
Based on the information obtained in this brief overview, the Triage Nurse elected to:
1. Immediately place the patient in an exam room for a more in-depth evaluation and initiation of treatment. Responsibility for the patient ' s care was transferred to the nurse assigned to the exam room in which the patient was placed.
2. Proceed immediately to the full triage process.
3. Consult the ED attending or charge nurse, as appropriate, for other disposition. Complete appropriate documentation.
The full triage process consisted of an evaluation of the patient's chief complaint including current medical history related to the chief complaint. It also included any pertinent medical history, any treatment for the chief complaint prior to arrival to the ED, current medications, allergies, and when appropriate, immunization status. The Triage Nurse was responsible for documentation of all information as specified on the Triage form including a full set of vital signs.
Based on the observations/assessments, the Triage Nurse elected to:
1. Initiate certain therapeutic measures as specified by standing orders and/or
2. Place the patient in an exam room and/or
3. Direct the patient to the waiting area to await exam room placement based on acuity ranking and room availability
4. Consult with ED attending or charge nurse, as appropriate, for other disposition. Complete appropriate documentation.
Triage Categories
Triage category guidelines were implemented following the Emergency Severity Index (ESI) Algorithm and had been developed to assist the triage nurse in making decisions about the categorization of patients for emergency care and to assure that care for the critically ill or injured was given first priority.
These were only guidelines. Each category was neither totally inclusive nor exclusive.
When in doubt, the triage nurse sought assistance from the charge nurse or attending physician on duty.
Factors other than acuity categorization and time of arrival could influence the order in which a patient was placed in an examination room for evaluation and treatment. Factors included but were not limited to:
1. The patient was an expected arrival for evaluation and treatment by a service or physician other than the ED service/physician and that physician was present and available to see the patient. These patients were placed in the first available, appropriate room as soon as the physician was ready to examine the patient.
2. Patients may be placed in rooms in order of priority and available resources.
Emergent (ESI Level 1)
ESI Level 1 was used for patients with conditions that may result in the loss of life or limb if not treated immediately. Patients with ESI 1 were immediately placed in a room after the initial triage assessment. A more complete assessment may be completed in the exam room. The attending physician or senior resident and the nurse assigned to the room in which the patient was placed were immediately notified by the triage nurse of the patient's need for service.
Urgent (ESI Level 2)
ESI 2 patient required prompt care. These patients should not wait to be seen. ESI 2 patients were placed in a room for treatment as soon as available. Registration could be completed at the bedside.
The triage nurse assesses the patient:
1. Is the patient a high-risk situation?
2. Is the patient newly confused, lethargic, or disoriented?
3. Is the patient in severe pain or distress?
If so, the patient was given the next available bed.
ESI Level 3, 4, and 5
Patients in these ESI levels generally need evaluation and treatment but time was not a critical factor.
Level 3 patient used 2 or more resources for treatment and disposition
3V (vertical) patients could tolerate being seated or seen in a seated position.
3H (horizontal) patients that could not tolerate being seated
Level 4 patients used 1 or more resources for treatment and disposition
Level 5 patients utilized no resources.
Patients in ESI Levels 3, 4, and 5 were directed to registration for completion of the registration process after the triage process was completed unless a bed was available.
These patients were placed in an exam room after completion of registration based on the time of arrival and room availability. These patients were generally placed in rooms for the exam only after all patients in ESI Level 2 had received a room assignment.
Some ESI Level 3, 4, and 5 may be eligible for FastTrack. Eligible patients were identified and may be seen in the FastTrack area ahead of patients in the Urgent category waiting for a regular exam room. Under no circumstances were the patient referred away from the ED prior to a physician medical screening examination.
Triage Delay
All patients began the triage process within 10 minutes of initial presentation in the ED.
When the triage nurse had multiple patients waiting for an assessment who had reached the ten-minute time limit, the triage nurse informed the charge nurse for assistance.
Continued review of the policy included an attached reference with the following information:
Danger zone vitals for a patient greater than 8 years of age were a heart rate of 100 beats per minute or greater; respiratory rate of greater than 20 breaths per minute; and oxygen saturation of less than 92%. Continued review revealed that when danger zone vital signs were taken, the triage nurse was to consider assigning an ESI 2 to the patient. Continued review of the policy references revealed the following examples of 'resources': laboratory test, x-rays, EKG, IV fluid administration, IV, IM or nebulized medication, specialty consultation, simple and complex procedures. Examples that were not considered 'resources' were: laboratory testing is done at the bedside, history and physical examination, IV insertion, oral medications, tetanus immunization, phone contact with other providers, simple wound care, provision of crutches, splints, or slings.
Review of the facility's policy number 177, titled 'Emergency Medical Treatment & Labor Act
(EMTALA) Policy', issued 7/1/00, last reviewed 7/16/18 revealed that all individuals who requested an examination for a possible emergency medical condition, including women in active labor were entitled to and received, the appropriate care as outlined in the Emergency Medical Treatment and Labor Act (EMTALA), 42 U.S.C., Section 1395 and all applicable federal regulations and interpretive guidelines promulgated thereafter.
Individuals were provided with an appropriate medical screening examination (MSE) and
stabilizing treatment prior to dismissal or transfer. Care was provided to individuals who sought emergency services without regard to their ability to pay, race, ethnicity, religion, national origin, citizenship, age, sex, preexisting medical condition, physical or mental handicap, or insurance status. Arriving to the hospital included:
1. Presenting to the facility's dedicated emergency department
2. The individual or representative acting on behalf requested an examination or treatment for a medical condition, or
3. A prudent layperson observer would conclude from the individual's appearance or behavior that the individual needed an examination or treatment of a medical condition.
The obligation for care was extended to individuals that presented on the hospital property requesting an examination or treatment for an emergency medical condition and/or any department of the hospital located within 250 yards of the hospital.
Further review of the policy revealed that Dedicated Emergency Departments (DED) were defined as the facility' s ED, the Children ' s Hospital ED, and the Labor and Delivery unit. An Emergency Medical Condition (EMC) was a medical condition that manifested itself by acute symptoms of sufficient severity (including severe pain, psychiatric disturbances, and /or symptoms of substance abuse) such that in the absence of immediate medical attention could be reasonably expected to either: place the health of the individual in serious jeopardy, serious impairment, serious dysfunction. A Medical Screening Exam (MSE) was the process required to reach, within reasonable clinical confidence, the point at which it can be determined whether a medical emergency does or does not exist. Triage was not equivalent to an MSE. If the exam did not reveal an EMC, the EMTALA obligations of AUMC ceased. If the exam revealed an EMC, the individual was stabilized or transferred, if appropriate. The adequacy (appropriateness) of an MSE depended on the presenting signs and symptoms elicited in the history. An MSE was a process and may involve multiple steps and reassessment over time to include diagnostic evaluation and/or consultation with specialty physicians as needed. If an individual left the premises prior to receiving an MSE, they are considered to have withdrawn their request for an MSE.
Definitions included but were not limited to:
Appropriate Transfer: A transfer to a medical facility in which the transferring hospital provided the medical treatment within its capacity which minimized the risks to the individual health. The receiving hospital had the capacity and qualified personnel for the treatment of the individual and agreed to accept the transfer of the individual.
Capability: The level of care that the facility personnel could provide within the training and scope of their professional license. This included the coverage available through the hospital on-call roster. The capability was measured by the physical space, equipment, supplies, and specialized services that the hospital provided.
Capacity: the facility was considered to have the capacity to treat a patient unless on diversion or saturation for a specific service type. Capacity included what the facility customarily did to accommodate patients in excess of occupancy limits.
Transfer: The movement (including discharge) of an individual outside a hospital facility at the direction of any person employed or affiliated with the hospital. This does not include the movement of an individual who left the facility without the permission of any such person.
Appropriate Medical Screening and Stabilization
A medical screening exam (MSE) the process required to reach, within reasonable clinical confidence, the point at which it could be determined whether a medical emergency did or did not exist. Triage was not equivalent to an MSE. If the MSE did not reveal an EMC, (Emergency Medical Condition) EMTALA obligations ceased. If the MSE revealed an EMC existed, the individual is stabilized or transferred, if appropriate. The adequacy of an MSE depended on the presenting signs and symptoms elicited in the history. An MSE is a process and could involve multiple steps and reassessment over time to include diagnostic evaluation and/or consultation with a specialty physician. The facility did not delay providing an MSE or further medical treatment to inquire about the individual's form of payment or insurance status. The facility could follow reasonable registration processes so long as it did not delay screening or treatment. It may be necessary to move an individual to another department to perform an MSE or to stabilize the condition.
Continued review of the policy revealed the facility had specialized capabilities and facilities (i.e., shock trauma, ICU, NICU, etc.) that were not available at all organizations and must accept appropriate transfers from inside the United States that required such specialized capabilities/facilities if the facility had the capacity to treat the individual.
The facility failed to evaluate for treatment P#1 timely, as she met criteria for an ESI 2 patient and was not seen for 45 minutes, delaying an appropriate medical screening. P#1 expired.
Tag No.: A2407
Based on medical records, initial assessment, autopsy report, Emergency Department Log, policy reviews, and interviews, the facility failed to provide stabilizing treatment as required for Patient #1 (P#1) for an emergency medical condition within a sample of one (P#1) of 20 patients. Patient #1 presented to the facility's Emergency Department (ED) with difficulty breathing, abnormal vital signs, heart rate of 170 beats per minute and pain score of 10 out of 10. P#1 was noted not breathing and without pulses upon initial assessment, and expired in the facility's ED.
Findings Include:
A review of the facility's Emergency Department (ED) central log revealed that P#1 was admitted at the facility ' s ED on 03/04/2019 at 6:56 p.m. with complaints of abdominal pain, fever, diarrhea, and vomiting.
Review of P#1's medical record revealed on 03/4/2019, P#1 's mother took P#1 to the ED for acting abnormal as well as worsening abdominal pain. The report indicated that P #1 was seen in triage area screaming out and hyperventilating.
P#1's medical record revealed at 7:04 p.m., P#1 was triaged (assessment by a nurse to determine the priority in which patients will be seen based on their chief complaint, signs, and symptoms) by a Registered Nurse (RN) as a level 3V {3V (vertical) patients could tolerate being seated or seen in a seated position}. P#1 reported that her pain was a 10 on a scale of 0 -10 (0 = No pain, 10 = severe pain).
P#1's medical record revealed P#1's vital signs at triage were: Temperature: 98.2 Fahrenheit (Pediatric normal range was 97.5 to 98.6). Heart Rate:170 (High) (Pediatric normal range was normal 75-118) Respiratory Rate: 22 (Pediatric normal range was 18-25) Blood pressure: 106/84(high) (Pediatric normal range was 97-115/57-76) Oxygen saturation: 100% (Pediatric normal range was 94-100%). P#1 had no known allergies, her past medication list included oseltamivir (Tamiflu brand name, used for influenza virus), Albuterol (used by asthmatic patient), cetirizine (antibiotics), ibuprofen (pain medicine), montelukast (prevent asthma attack). Patient #1 was noted to have a sickle cell trait.
Review of P#1's initial assessment by MD BB revealed P#1 was apneic (temporary cessation of breathing) and without pulses on initial assessment. CPR was immediately initiated, and P #1's pupils were assessed to be approximately 6mm, fixed, and dilated (possible sign of coma). P#1's assessment revealed P#1 had coffee ground colored (bloody) emesis (vomit) during bag-valve breaths which were subsequently suctioned. MD BB documented the respiratory department was paged and P#1 was intubated. MD BB documented P#1's heart revealed oscillation between pulselessness (absence of heart activity) and spontaneous circulation (ROSC) with no pericardial effusion (fluid back up around the heart). The physician documented P#1's time of death as 9:04 p.m. on 3/4/19.
A review of the facility's ED record revealed that P#1 final diagnosis included cardiopulmonary arrest (cessation of adequate heart function and respiration and results in death), gastrointestinal (GI) bleed, hypovolemic shock (loss of fluid that makes it impossible for the heart to pump a sufficient amount of blood to your body) Influenza-like illness, and pulmonary hemorrhage (acute bleeding from the lung). Patient #1's disposition was expired, to coroner officer.
A review of P#1's autopsy report dated 03/21/2019, revealed P#1 expired due to diffuse alveolar damage (changes that occurred to the structure of the lungs during injury or disease) and tracheitis (inflammation of the trachea/windpipe) on 3/4/19 at 9:04 p.m. The report documented P #1 was unresponsive in the Pediatric ED waiting room. The staff-initiated CPR and continued resuscitative measures until P#1 expired.
An interview was conducted with the Chief Medical Officer (CMO) on 4/27/21 at 9:15 a.m. CMO stated a triage level (3V) was appropriate for Patient #1 because he did not think anything was abnormal from Patient #1's vital signs.
An interview was conducted with the ED Lead Nurse (RN) EE on 4/27/21 at 10:00 a.m. RN EE explained she worked the night of the incident. She stated she came out of the ED room, and looked at the ED log of patients in the waiting room. RN EE said she saw P#1's heart rate on her workstation, went to the waiting room, and called P#1's name but no one responded. RN EE explained she documented on P#1's flow sheet that she had attempted to call P#1 then went back to the waiting room to call another patient. RN EE said at that moment she heard P#1's mother say, "please help me." RN EE stated she saw P#1 in a wagon, unconscious with her eyes rolled to the back. RN EE said she immediately took P#1 to the trauma room and a code was called. RN EE said on her workstation she could see age, chief complain, vital signs of patient waiting to be seen in the waiting room. RN EE said she would have triaged P#1 as an (ESI Level 2) and said that decision was subjective, and that she was not the triage nurse the night the incident occurred.
During an interview with the ED Director (ED) on 4/27/21 at 10:30 a.m., ED said when the hospital conducted their internal investigation regarding the incident, they determined P#1 could have been triage as ESI level 2. ED explained that on the night of the incident, there were no beds available and further stated chances were if P#1 was triaged as a ESI-2, P#1 would still have to wait.
Review of the facility's policy number 177, titled "Emergency Medical Treatment & Labor Act
(EMTALA) Policy", issued 7/1/00, last reviewed 7/16/18 revealed that all individuals who requested an examination for a possible emergency medical condition, including women in active labor were entitled to and received, the appropriate care as outlined in the Emergency Medical Treatment and Labor Act (EMTALA), 42 U.S.C., Section 1395 and all applicable federal regulations and interpretive guidelines promulgated thereafter. Individuals were provided with an appropriate medical screening examination (MSE) and stabilizing treatment prior to dismissal or transfer. Care was provided to individuals who sought emergency services without regard to their ability to pay, race, ethnicity, religion, national origin, citizenship, age, sex, preexisting medical condition, physical or mental handicap, or insurance status. Arriving at the hospital included:
1. Presenting to the facility's dedicated emergency department
2. The individual or representative acting on behalf requested an examination or treatment for a medical condition, or
3. A prudent layperson observer would conclude from the individual ' s appearance or behavior that the individual needed an examination or treatment of a medical condition.
The obligation for care was extended to individuals that presented on the hospital property requesting an examination or treatment for an emergency medical condition and/or any department of the hospital located within 250 yards of the hospital.
Further review of the policy revealed that Dedicated Emergency Departments (DED) were defined as the facility ' s ED, the Children ' s Hospital ED, and the Labor and Delivery unit. An Emergency Medical Condition (EMC) was a medical condition that manifested itself by acute symptoms of sufficient severity (including severe pain, psychiatric disturbances, and /or symptoms of substance abuse) such that in the absence of immediate medical attention could be reasonably expected to either: place the health of the individual in serious jeopardy, serious impairment, serious dysfunction
In addition, the policy revealed the following guidelines for an "Appropriate Medical Screening and Stabilization":
A medical screening exam (MSE) the process required to reach, within reasonable clinical confidence, the point at which it could be determined whether a medical emergency did or did not exist. Triage was not equivalent to an MSE. The adequacy of an MSE depended on presenting signs and symptoms elicited in the history. An MSE is a process and could involve multiple steps and reassessment over time to include diagnostic evaluation and/or consultation with a specialty physician. The facility could follow reasonable registration processes so long as it did not delay screening or treatment. It may be necessary to move an individual to another department to perform an MSE or to stabilize the condition.
Continued review of the policy revealed that the facility had specialized capabilities and facilities (i.e., shock trauma, ICU, NICU, etc.) that were not available at all organizations and must accept appropriate transfers from inside the United States that required such specialized capabilities/facilities if the facility had the capacity to treat the individual.
A review of the facility's policy number 567 titled "Pain Assessment" last reviewed 10/11/2016 revealed the policy outlined a plan for effective pain management in accordance with evidenced-based practice and nationally accepted guidelines and standards. All patients were guaranteed the right to appropriate assessment and management of their pain regardless of age, gender, disease entity, prognosis, psychosocial, cultural, spiritual, ethnic, and/or religious beliefs. Pain control approaches were collaborative in nature and utilized input from all health care disciplines and the patients and patient's representative. Both pharmacological and non-pharmacological interventions were used. Any deviation from the policy was permitted as long as additional protocols for IV opioid administration and monitoring were reviewed and approved by the Pain Committee.
P#1 had difficulty breathing, abnormal vital signs of heart rate of 170, pain score of 10 out of 10, was not seen for 45 minutes, and expired in the ED before her condition stabilized.