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Based on document review and interviews, the facility failed to comply with the Medicare provider agreement as defined in §489.20 and §489.24 related to Emergency Medical Treatment and Labor Act (EMTALA) requirements.

FINDINGS

1. The facility failed to meet the following requirements under the EMTALA regulations:

Tag 2407: §489.24(d) Necessary Stabilizing Treatment for Emergency Medical Conditions (1) General. Subject to the provisions of paragraph (d)(2) of this section, if any individual (whether or not eligible for Medicare benefits) comes to a hospital and the hospital determines that the individual has an emergency medical condition, the hospital must provide either-- (i) Within the capabilities of the staff and facilities available at the hospital, for further medical examination and treatment as required to stabilize the medical condition. (ii) For transfer of the individual to another medical facility in accordance with paragraph (e) of this section. (2) Exception: Application to Inpatients. (i) If a hospital has screened an individual under paragraph (a) of this section and found the individual to have an emergency medical condition, and admits that individual as an inpatient in good faith in order to stabilize the emergency medical condition, the hospital has satisfied its special responsibilities under this section with respect to that individual (ii) This section is not applicable to an inpatient who was admitted for elective (non-emergency) diagnosis or treatment. (iii) A hospital is required by the conditions of participation for hospitals under Part 482 of this chapter to provide care to its inpatients in accordance with those conditions of participation. (3) Refusal to consent to treatment. A hospital meets the requirements of paragraph (d)(1)(i) of this section with respect to an individual if the hospital offers the individual the further medical examination and treatment described in that paragraph and informs the individual (or a person acting on the individual's behalf) of the risks and benefits to the individual of the examination and treatment, but the individual (or a person acting on the individual's behalf) does not consent to the examination or treatment. The medical record must contain a description of the examination, treatment, or both if applicable, that was refused by or on behalf of the individual. The hospital must take all reasonable steps to secure the individual's written informed refusal (or that of the person acting on his or her behalf). The written document should indicate that the person has been informed of the risks and benefits of the examination or treatment, or both. Based on document review and interviews, the facility failed to comply with the Emergency Medical Treatment and Labor Act (EMTALA). Specifically, the facility failed to provide stabilizing treatment for a patient who experienced cardiac arrest. (Patient #7)

Based on document review and interviews, the facility failed to comply with the Emergency Medical Treatment and Labor Act (EMTALA). Specifically, the facility failed to provide stabilizing treatment for a patient who experienced cardiac arrest. (Patient #7)

Findings include:

Facility policies:

The EMTALA- Medical Screening Examination (MSE) and Stabilization Treatment policy read, an emergency medical condition (EMC) was defined as a medical condition manifesting itself by acute symptoms of sufficient severity such that the absence of immediate medical attention could reasonably be expected to result in the following: placing the individual in serious jeopardy, serious impairment to bodily functions, or serious dysfunction of any bodily organ or part. Stabilizing treatment was defined as the treatment necessary to stabilize an EMC. If the MSE demonstrates that an EMC exists, the facility will provide stabilizing treatment within the facility's capabilities.

References:

The American Heart Association (AHA) Advanced Cardiac Life Support (ACLS) Adult Cardiac Arrest Algorithm read, quantitative waveform capnography (a noninvasive method for continuously measuring end-tidal carbon dioxide (ETCO2) in expired air) should be used to determine the quality of cardiopulmonary resuscitation (CPR). If the partial pressure of end-tidal carbon dioxide (ETCO2) is low or decreasing, the quality of CPR should be reassessed. Abrupt sustained increase in ETCO2 indicates return of spontaneous circulation (ROSC).

The algorithm for ventricular fibrillation (V-fib- a dangerous heart rhythm that occurs when the heart's lower chambers quiver instead of pumping blood) read, start CPR. If V-fib is present, shock (defibrillate) and resume CPR for two minutes. After two minutes, check for a pulse and if V-fib persists, defibrillate and resume CPR. Administer epinephrine (adrenaline medication given to increase blood flow to the heart and brain during CPR) every three to five minutes. Consider an advanced airway and capnography. After two minutes of CPR, check for a pulse and if V-fib persists, defibrillate and resume CPR for 2 minutes. Treat reversible causes.

The algorithm for pulseless electrical activity (PEA- a medical emergency that occurs when the heart stops and the electrical activity is too weak to generate a heartbeat or pump blood) read, if PEA or asystole (when your heart's electrical system fails entirely, which causes the heart to stop pumping) is present, start CPR and administer epinephrine as soon as possible, and then every three to five minutes. After two minutes, check for a pulse. If the heart rhythm is shockable (V-fib), defibrillate. If the rhythm is not shockable (PEA/asystole), resume CPR for two minutes and treat reversible causes.

The 2020 AHA Guidelines for CPR and Emergency Cardiovascular Care, Part 3 Adult Basic and Advanced Life Support, retrieved from https://cpr.heart.org/en/resuscitation-science/cpr-and
-ecc-guidelines/adult-basic-and-advanced-life-support read, CPR obscures interpretation of the underlying rhythm because of the artifact created by chest compressions. This makes it difficult to plan the next step of care and can potentially delay or even misdirect drug therapies if given blindly based on the patient's presumed, but not actual, underlying rhythm.

1. The facility failed to provide stabilizing treatment for a patient who experienced cardiac arrest.

A. Document Review

i. Medical record review revealed Patient #7 presented to the emergency department (ED) on 3/24/24 at 9:31 a.m. with chest pain. At 9:37 a.m., six minutes after arrival, Patient #7 experienced cardiac arrest (when the heart stops beating suddenly).

Review of Provider #1's report revealed CPR was initiated immediately. After two attempts, Patient #7 was intubated (a tube inserted into the airway) and a second intravenous (IV) access was established by nursing staff. Provider #1 attempted to place a central line (used to administer medications or fluids that would harm a smaller vein) during compressions. The wire bent and they were unable to pass the catheter and abandoned the attempt. Patient #7 received several doses of medications without regaining a pulse.

Provider #1's report also revealed Patient #7's predominant heart rhythm was asystole/PEA. There was initial concern for V-fib for a few seconds after Patient #7 was placed on the cardiac (heart) monitor. Provider #1's report read, given the sudden onset of decline, cardiac arrest was favored, thus defibrillation was attempted several times in between compressions without success. Patient #7's time of death was 10:05 a.m.

ii. Review of the Emergency CPR Evaluation of Response to Code document in the medical record revealed the following:

a. At 9:38 a.m., Patient #7's initial heart rhythm was V-fib. No additional heart rhythms were documented throughout the event which ended at 10:05. This was in contrast to Provider #1's report which revealed Patient #7's predominant heart rhythm was asystole/PEA.

b. Patient #7 was defibrillated five times throughout the event. This was also in contrast to Provider #1's report which revealed Patient #7's predominant heart rhythm was asystole/PEA. Additionally, this was in contrast to the AHA ACLS Adult Cardiac Arrest Algorithm which read, asystole/PEA was not a shockable heart rhythm.

c. Patient #7 was defibrillated at 9:42 a.m., four minutes after V-fib was identified. Defibrillation also occurred at 9:45 a.m. and 9:48 a.m., at three minute intervals. Patient #7 was additionally defibrillated at 9:52 a.m. (four minutes later) and at 9:55 a.m. (three minutes later). This was in contrast to the AHA ACLS Adult Cardiac Arrest Algorithm which read, defibrillation should occur every two minutes when pulses were assessed.

d. ETCO2 monitoring did not occur for Patient #7. This was in contrast to the AHA ACLS Adult Cardiac Arrest Algorithm which read, ETCO2 monitoring should have been used to determine the quality of cardiopulmonary resuscitation.

e. The last two doses of epinephrine were administered at 9:49 a.m. and 9:57 a.m., eight minutes apart. No additional doses of epinephrine were administered from 9:57 a.m. until the event ended at 10:05 a.m., eight minutes after the last dose of epinephrine was administered. This was in contrast to the AHA ACLS Adult Cardiac Arrest Algorithm which read, epinephrine should have been administered every three to five minutes.

These examples were in contrast to the The EMTALA- MSE and Stabilization Treatment policy which read, if an EMC existed, the facility would provide stabilizing treatment within the facility's capabilities.

iii. Review of the safety event log revealed, on 5/22/24, the facility's code blue (cardiac arrest) committee performed an audit of Patient #7's event and found the following concerns:

a. Delay in the time it took for Patient #7 to receive an initial defibrillation.

b. Defibrillation occurred every three minutes when rhythm checks should have occurred every two minutes.

c. Heart rhythms were not documented throughout the code event.

d. Provider #1's report indicated Patient #7 was in asystole/PEA, however defibrillation still occurred.

Additionally, the safety event log revealed the event would be sent for provider peer review.

iv. Review of requested provider peer review information received on 8/27/24 revealed the provider's peer review was in process, approximately three months after the code blue committee's safety event was placed and five months after the event occurred.

v. On 8/28/24 at 8:21 a.m., email correspondence to the surveyor from regulatory consultant (Consultant) #2 revealed no education had been required for Provider #1 in response to the safety event, as the peer review was in process.

vi. On 8/27/24 at 4:38 p.m., upon request, the facility was unable to provide verification of Provider #1's ACLS certification.

vii. Review of Emergency Medicine Delineation of Privileges documentation revealed board certified providers (a licensed medical professional who has undergone additional training in a specialty of their choice and has demonstrated their mastery of that specialty to a certifying body) were not required to have ACLS, pediatric advanced life support (PALS), or advanced trauma life support (ATLS) certifications.

viii. On 8/29/24 at 8:12 a.m., email correspondence to the surveyor from Consultant #2 revealed they had confirmed with medical staff services that there was not a requirement for ACLS continuing medical education (CME) for Provider #1.

B. Interviews

i. Interviews with staff revealed AHA ACLS guidelines changed periodically. Interviews revealed ED nurses were required to renew ACLS certifications every two years and were also required to complete quarterly ACLS training. Interviews also revealed board certified ED providers, who were in the role of team leader during cardiac arrest events, were not required to maintain ACLS certification.

a. On 8/28/24 at 11:17 a.m., an interview was conducted with registered nurse (RN) #3. RN #3 stated an EMC was anything that required immediate lifesaving interventions to prevent a bad patient outcome. RN #3 stated ACLS was the treatment for cardiac arrest. RN #3 stated ACLS algorithms gave step by step instructions for interventions required for each heart rhythm. RN #3 stated nurses were certified in ACLS every two years and were required to complete quarterly ACLS training. RN #3 stated being exposed to ACLS more frequently helped to retain the knowledge. RN #2 stated if nurses did not have, or did not renew their ACLS certifications they were not allowed to work until the certification was completed.

Additionally, RN #3 stated ED providers were the team leader during cardiac arrest events. RN #3 stated ED providers instructed the nurses on what medications to administer and when to defibrillate patients. RN #3 stated it was important to follow ACLS guidelines because the guidelines were a proven process for the best chance of good patient outcomes. RN #3 stated the AHA sometimes changed their guidelines, and the AHA's data and research led to algorithms which improved patient outcomes.

b. On 8/28/24 at 1:00 p.m., an interview was conducted with RN #4, who provided care to Patient #7 during the cardiac arrest event. RN #4 stated ACLS protocols were used to stabilize cardiac arrest. RN #4 stated ED nurses were required to maintain their ACLS certifications. RN #4 also stated ED nurses completed quarterly ACLS training to provide more opportunities for exposure and practice. RN #4 stated nurses were not allowed to work in the ED without a valid ACLS certification.

Additionally, RN #4 stated ED providers were the team leader during cardiac arrest events. RN #4 stated the ED providers assigned roles to staff, instructed nurses on when to administer medications, and instructed staff on when to start and stop compressions. RN #4 stated ED providers ran code blues minute by minute.

RN #4 stated Patient #7 was awake and alert when they came into the ED. RN #4 stated Patient #7 went into V-fib shortly after arrival. RN #4 stated when Patient #7 went into a V-fib arrest, chest compressions were started and Patient #7 was defibrillated multiple times. RN #4 stated defibrillation was the treatment for V-fib. RN #4 stated PEA had a different algorithm and did not require defibrillation.

This was in contrast to Provider #1's report which revealed Patient #7's predominant heart rhythm was asystole/PEA and defibrillation was attempted several times.

Furthermore, RN #4 stated ACLS algorithms were evidence-based guidelines for the best patient outcomes.

c. On 8/28/24 at 2:58 p.m., an interview was conducted with Provider #1, who provided care to Patient #7. Provider #1 stated they were privileged to practice at other facilities within the hospital system. Provider #1 stated an EMC required immediate recognition and action. Provider #1 stated stabilizing treatment for cardiac arrest would depend on a patient's predominant heart rhythm. Provider #1 stated treatment for V-fib would be defibrillation and CPR. Provider #1 stated treatment for PEA would be CPR, epinephrine, and PEA would not be defibrillated.

Provider #1 stated they never identified V-fib for Patient #7. Provider #1 stated Patient #7's initial heart rhythm was PEA. Provider #1 stated they questioned if Patient #7 was in V-fib during compressions and when compressions were stopped, Patient #7 was in PEA. Provider #1 stated the V-fib algorithm was used because there were questions as to whether Patient #7 was in V-fib during compressions.

This was in contrast to the Emergency CPR Evaluation of Response to Code document and interview with RN #4, which revealed Patient #7's initial rhythm was V-fib. This was also in contrast to the AHA ACLS Adult Cardiac Arrest Algorithm which read, rhythm checks were to be conducted after two minutes of CPR.

Additionally, Provider #1 stated no one from leadership had contacted them to ask questions about the event, other than the code blue committee. Provider #1 also stated they had not been provided with any ACLS education or training since the safety event was placed on 5/22/24.

Furthermore, Provider #1 stated they were certified in ACLS in 2008. Provider #1 stated they were required to complete CMEs to stay current with current ACLS guidelines.

This was in contrast to the email correspondence received from Consultant #2 on 8/29/24 at 8:12 a.m., which revealed there was not a requirement for ACLS CME for Provider #1.

Provider #1 stated it was important to follow ACLS guidelines, as the guidelines were best evidence based practice at the forefront of resuscitation. Provider #1 stated patients were at risk of increased morbidity and mortality if ACLS guidelines were not followed.

d. On 8/29/24 at 7:30 a.m., an interview was conducted with chief medical officer (CMO) #5. CMO #5 stated ACLS algorithms should have been followed when a patient experienced PEA or V-fib. CMO #5 stated Patient #7's case was in the peer review process. CMO #5 stated the need for additional education or training would be determined after the peer review process was completed. CMO #5 stated training for nurses was different from the requirements for credentialing and privileging for providers. Additionally, CMO #5 stated board certification ensured providers were competent to perform ACLS.

This was in contrast to Patient #7's medical record review, which revealed several examples in which stabilizing treatment was not provided by Provider #1 when ACLS guidelines were not followed.