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

FINDINGS

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

Tag 2406: (c)) Appropriate Medical Screening Examination. Based on interviews and record review, the facility failed to ensure patients presenting to the emergency department (ED) with a potential emergency medical condition (EMC) received a medical screening exam (MSE). Specifically, the facility failed to ensure an MSE was completed in one of one patients who received oral cardioversion (medications administered in order to convert an abnormal heart rhythm to a normal rhythm) (Patient #18). Additionally, the facility failed to ensure an MSE was completed in three of six medical records reviewed of individuals at greater than 20 weeks gestation when they presented to the ED (Patients #2, #14, and #15). Lastly, the facility failed to ensure an appropriate MSE was performed in two of three medical records reviewed of patients presenting with suicidal ideations (SI) and were discharged. (Patients #9 and #22).

Tag 2407: (d)(3)) Stabilizing Treatment. Based on interviews and record review, the facility failed to ensure patients were stable prior to transfer or discharge. Specifically, the facility failed to ensure a patient was monitored to ensure stabilization prior to discharge in one of one patient medical records reviewed where oral cardioversion (medications administered in order to convert an abnormal heart rhythm to a normal rhythm) was attempted (Patient #18). Additionally, the facility failed to ensure patients with suicidal ideation received stabilizing psychiatric treatment before discharge in two of three patients reviewed who presented with suicidal ideation (Patients #9 and #22).

Based on interviews and record review, the facility failed to ensure patients presenting to the emergency department (ED) with a potential emergency medical condition (EMC) received a medical screening exam (MSE). Specifically, the facility failed to ensure an MSE was completed in one of one patients who received oral cardioversion (medications administered in order to convert an abnormal heart rhythm to a normal rhythm) (Patient #18). Additionally, the facility failed to ensure an MSE was completed in three of six medical records reviewed of individuals at greater than 20 weeks gestation when they presented to the ED (Patients #2, #14, and #15). Lastly, the facility failed to ensure an appropriate MSE was performed in two of three medical records reviewed of patients presenting with suicidal ideations (SI) and were discharged. (Patients #9 and #22). (Cross-reference A-2407).

Findings include:

Facility policies:

The EMTALA policy read, an emergency medical condition or EMC is a medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain and/or a Psychiatric Emergency) such that the absence of immediate medical attention could reasonably be expected to result in: a. Placing the individual (or with respect to a pregnant woman, the health of the woman or her unborn child) in serious jeopardy; b. Serious impairment to bodily functions; or c. Serious dysfunction of any bodily organ or part.

With respect to a pregnant woman who is having contractions (true labor is presumed unless the physician/QMP, after a period of observation, certifies the presence of false labor): a. Inadequate time to effect a safe Transfer to another Hospital before delivery; or b, the transfer may pose a threat to the health or safety of the woman or unborn child.

Discharge requirements: A patient will be discharged if, following the MSE, the physician or QMP determines that the patient does not have an EMC or is stable for discharge. Prior to discharge, the patient with an EMC is given a plan of care and discharge instructions, including a plan for appropriate follow-up care if necessary.

A medical screening exam (MSE) is offered to individuals on the campus of the hospital with a dedicated ED who request emergency medical services, on whose behalf such services are requested, or, in the absence of such a request, whose appearance or behavior would cause a prudent layperson observer to believe that such individuals need emergency examination or treatment. An MSE will be conducted to determine whether the Patient has an EMC. The Hospital will conduct a consistent MSE, in a non-discriminatory matter, for all Patients with similar medical conditions. The MSE is an ongoing process requiring continuing monitoring based on the Patient's needs and must continue until the EMC is stabilized or the Patient is admitted or appropriately transferred.

Documentation of the following events should contain at a minimum the following information: For triage, the clinical assessment of the presenting symptoms at the time of arrival and presenting complaint. The medical screening exam documentation should include the Physician/QMP assessment and orders, intervention and treatments, and the patient/fetus response to treatment. Additionally, the MSE should include documentation of continued monitoring.

A psychiatric emergency is defined as a situation where a patient is a danger to himself or others by reason of aggressive conduct to inability to perceive or appreciate danger. Symptoms of substance abuse (drug and/or alcohol) requiring immediate detoxification are also considered within the definition of an emergency medical condition, and stabilizing treatment must be rendered.

The Laboring and Non-Laboring Obstetrical Patient Triage Assessment and Disposition - Presenting to the ED or OB Triage policy read, when the patient's condition permits, all pregnant patients that present to the ED will be quickly registered to include asking the patient's gestational age or timing of recent birth/delivery.

Obstetrical (OB) patients greater than 20 weeks gestation by dates and/or history who present to the ED shall be assessed as being unstable and presenting with a life-threatening event that may be either medical or trauma-induced. For patients who have a gestational age greater than 24 weeks presenting to the ED, the ED shall notify the OB provider.

OB Triage includes performing and documenting in the patient's record the chief complaint, possible complications of pregnancy, gestational age of the fetus, fetal heart tones (FHT) when applicable/possible, additional assessments as needed, and vital signs.

The Safety Precautions Suicide, Danger to Self, and Danger to Others in Non-behavioral Health Settings for Adults, Children, and Adolescents policy read, the purpose is to promote patient safety through screening and early identification and detection of patients at risk for self-harm or suicide or of harm to others. Additionally, the purpose is to provide guidelines for the screening of such individuals, and appropriate interventions to maintain a safe environment for the patient and others.

A behavioral health consult is when the patient is assessed by any licensed independent practitioner whose scope of practice includes the ability to assess suicide/homicide risk, initiate commitment procedures for involuntary psychiatric hospitalization, or otherwise facilitate prompt access to mental health services. The suicide risk assessment is the clinical data set forming the basis for suicide prevention practices and interventions. Suicide risk assessment includes assessment of ideation (thoughts), intent (intention to act on thoughts), plan (specific method), and access to means (is the method plausible).

Patients should be screened for danger to themselves upon presentation using the C-SSRS Screening tool. Initiate the response based on the results of the patient screening. A behavioral health consult should be obtained for any patient believed to be a danger to self or others.

References:

The Flecainide drug reference read, Flecainide is contraindicated in patients with cardiogenic shock. Electrolyte disturbances, particularly potassium and sodium, can exacerbate or precipitate Flecainide cardiotoxicity. Electrolyte disturbances should be corrected before initiating therapy and monitored periodically throughout treatment. This drug should be considered a narrow therapeutic index (NTI) drug as small differences in dose or blood concentrations may lead to serious therapeutic failures or adverse drug reactions. Additional and/or more frequent monitoring should be done to ensure receipt of an effective dose while avoiding unnecessary toxicities. Flecainide should be used cautiously in patients with a history of CHF or myocardial dysfunction. Electrolyte disturbances (i.e., potassium, sodium) should be corrected before initiating Flecainide treatment. Monitoring of electrolytes (i.e., potassium, sodium) periodically has been recommended in high-risk patients in order to prevent Flecainide cardiotoxicity.

The report of the American College of Cardiology/American Heart Association (AHA) Task Force on Practice Guidelines and the Heart Rhythm Society Guidelines for the Management of Patients with Atrial Fibrillation (a-fib) provided Pharmacological Cardioversion Recommendations. Flecainide is useful for pharmacological cardioversion of a-fib provided contraindications to the selected drug are absent. Flecainide in addition to a beta blocker is reasonable to terminate a-fib outside of the hospital once this treatment has been observed to be safe in a monitored setting for selected patients. Antiarrhythmic drugs can be administered for attempted conversion of AF to sinus rhythm or to facilitate electrical cardioversion. Electrocardiographic monitoring should be continued for four hours after administration.

The American College of Obstetricians and Gynecologists (ACOG) Hospital-Based Triage of Obstetric Patients, dated July 2016 and provided by the facility read, the federal Emergency Medical Treatment and Labor Act (EMTALA) requires an initial medical screening examination to determine if a true medical emergency exists; in the case of a pregnant woman, this includes evaluation of the woman and the fetus. The medical condition of a woman having contractions is not considered an emergency if there is adequate time for her safe transfer before delivery or if the transfer will not pose a threat to the health or safety of the woman or the fetus.

Elaborating on key principles outlined in Guidelines for Perinatal Care, Seventh Edition, and in Liability in Triage: Management of EMTALA Regulations and Common Obstetric Risks, the essential legal requirements under EMTALA related to obstetric care include the following: A woman in labor is considered unstable from the latent phase through delivery of the placenta if there is inadequate time to safely transfer her to another hospital before delivery or if that transfer may pose a threat to her or her fetus's health or safety. According to EMTALA, if a qualified medical professional is able to determine that a woman with contractions is in "false labor" after a reasonable period of observation, then the patient's condition can be considered stable, and they would be eligible for transfer or release. In the situation of preterm labor or preterm premature rupture of membranes, transport of the woman in labor is recommended if time allows.
Typical triage protocols involve an initial assessment and decision about the priority level for evaluation. In the case of the pregnant patient, this assessment may be conducted by a registered nurse, certified nurse-midwife or certified midwife, nurse practitioner, physician assistant, or physician as designated by hospital policy. The healthcare provider performing triage should assign the patient's acuity during the first encounter. Triage is followed by the complete evaluation of the woman and the fetus by a healthcare provider with skills and training appropriate to evaluate the issues identified during triage. The American College of Obstetricians and Gynecologists Guidelines for Perinatal Care, Seventh Edition, provides further information on what is necessary for this evaluation.

The American College of Obstetricians and Gynecologists' Guidelines for Perinatal Care, Eighth Edition, dated September 2017 read, the initial assessment may be conducted by an RN, certified nurse-midwife or certified midwife, nurse practitioner, physician assistant, or physician as designated by the hospital policy. The health care provider performing triage should assign the patient's acuity during the first encounter which minimally includes assessment of the following: Maternal vital signs, fetal heart rate, uterine contractions, reason for presentation, the status of labor (presence of uterine contractions, vaginal bleeding, the status of membranes), women's perception of fetal movement, and any high risk medical or obstetric conditions as identified by a review of history or the woman's report.

Both facilities and professionals providing health care to pregnant women need to understand their obligations under federal and state law. The EMTALA defines the responsibilities of the transferring and receiving facilities and practitioners. Federal law requires all Medicare participating hospitals to provide an appropriate medical screening examination for any individual seeking medical treatment at an emergency department to determine whether the patient has an emergency medical condition.

False labor is defined as uterine contractions in the absence of cervical change. Treatment for this condition is based on individual circumstances. Women who are having uterine contractions and may not yet be in latent or active labor may be observed for evidence of cervical change in a casual, comfortable area. The woman may be discharged after observation and evaluation by appropriate hospital-designated personnel and assurance of maternal and fetal wellbeing.

A nonstress test uses fetal heart rate (FHR) patterns and accelerations as an indicator of fetal well-being. To perform an NST, the FHR is monitored with an external transducer for at least 20 minutes. The tracing is observed for FHR accelerations.

The diagnosis of membrane rupture is confirmed by the visualization of fluid passing through the cervical canal and pooling in the vagina or a basic pH test of vaginal fluid.

Appendix G under the Guidelines for Perinatal Care read special requirements apply for screening pregnant women in the emergency department. The health of the fetus must be considered in deciding whether a pregnant patient has an emergency medical condition. A pregnant patient having contractions is in "true labor" and therefore, must be determined to have an emergency medical condition unless a physician, certified nurse midwife or other qualified medical professional certifies she are in false labor. A pregnant patient having contractions also has an emergency medical condition if transferring her to another facility would threaten her health or the health of the fetus. If the patient has been observed and diagnosed with false labor, she do not have an emergency medical condition. If it is determined that a pregnant patient having contractions has an emergency medical condition, EMTALA considers that she are not stabilized until the baby and placenta are delivered.

If a patient has an emergency medical condition, there are two options depending on the circumstances and the hospital's capabilities: Treat and stabilize the patient. Transfer the patient to another hospital that is better able to provide necessary care.

1. The facility failed to ensure a medical screening exam (MSE) was conducted on a patient who received oral cardioversion treatment.

i. On 4/22/23 at 2:36 a.m., Patient #18 arrived at the emergency department (ED) with the chief complaint of shortness of breath (SOB). At 2:46 a.m., Patient #18's vital signs were documented as follows: blood pressure (BP) of 123/109 (normal BP was 120/80), heart rate (HR) of 142 beats per minute (bpm) (normal heart rate was between 60-100), oxygen saturation of 93% (normal oxygen saturation was above 9, and a respiratory rate (RR) of 30 breaths per minute. Further assessment showed an electrocardiogram (EKG) was conducted and revealed the patient was in atrial fibrillation (an irregular and rapid heart rhythm).

There was no evidence additional testing was performed to determine a differential diagnosis to include a troponin (a lab test used to determine if a patient was experiencing a heart attack).

ii. At 3:26 a.m., a provider note was entered and read, the patient came in without chest pain and had an increased SOB after the patient had stopped taking their metoprolol (a medication used to lower blood pressure and heart rate) five days earlier. The note further read there was a concern Patient #18 had possible fluid overload as well as congestive heart failure (CHF). The provider noted the plan was to provide the patient with Flecainide (a medication used to treat an irregular heart rhythm) to convert the patient's irregular heart rhythm to a regular heart rhythm.

iii. According to Patient #18's medication administration record (MAR), at 3:46 a.m. Patient #18 received 300 milligrams (mg) of Flecainide.

iv. At 5:22 a.m., a provider note read, the patient's heart rhythm did not convert after the administration of Flecainide. Patient #18 was instructed to take her home dose of metoprolol as scheduled when they normally took medications after discharge. Patient #18 was discharged home at 5:43 a.m., two hours after the Flecanide administration.

There was no evidence an EKG was performed prior to the patient's discharge.

The care provided to Patient #18 was in contrast to the AHA guidelines for the management of patients with a-fib which read that monitoring should have been continued for four hours after administration of antiarrhythmic drugs.

Additionally, the care of Patient #18 was in contrast to the EMTALA policy which read, a patient will be discharged if, following the MSE, the physician or QMP determines that the patient does not have an EMC or is stable for discharge.

2. The facility failed to ensure a medical screening exam (MSE) was conducted on pregnant individuals who presented to the emergency department at greater than 20 weeks gestation to determine if an emergency medical condition (EMC) existed for both the mother and the fetus.

A. Review of medical records revealed individuals at greater than 20 weeks gestation who presented to the ED did not receive a thorough medical screening exam (MSE).

i. On 10/22/23 at 9:45 p.m., Patient #2 presented to the ED and stated they were 36 weeks pregnant and were having contractions every five minutes. A note written by Provider #9 at 9:47 p.m. read, the patient did not have any bleeding or discharge. The note further read the patient was told they would be transferred to another facility because the facility did not have labor and delivery (L&D) services. It was further explained the process would take some time due to needing to find an accepting facility and provider and to set up transport. The patient stated they wanted to leave and drive themselves rather than wait. Provider #9 stated to the patient they would be leaving against medical advice (AMA).

A review of Patient #2's flowsheet documentation revealed vital signs were obtained upon the patient's arrival at the ED. There was no indication the patient was assessed for active labor to include fetal heart rate monitoring, monitoring of uterine contractions, and the status of labor. Additionally, there was no indication the fetus was assessed for an emergency medical condition.

This was in contrast to the EMTALA policy which read, an MSE was an ongoing process requiring continuing monitoring based on the patient's needs and must continue until the EMC was stabilized or the patient was appropriately transferred. Documentation of the MSE should have included the physical assessment and orders, intervention and treatments, the patient/fetus response to treatment, and continued monitoring. If an individual refused examination or treatment, the individual would be informed of the hospital's obligations under the EMTALA law and the hospital's willingness to provide an MSE.

ii. On 8/16/23 at 1:51 p.m., Patient #14 presented to the ED by ambulance due to a motor vehicle accident. Patient #14 was 28 weeks pregnant and had been experiencing pelvic pain. A review of the patient's record revealed vital signs were obtained on the patient, however there was no evidence FHTs were obtained.

A review of the provider's note read, there was no evidence of trauma to the abdomen and there was low suspicion for traumatic injury. There was no evidence further assessment of trauma was conducted on the patient. Additionally, there was no evidence an ultrasound was obtained of the fetus or the abdomen of the patient.

This was in contrast to the EMTALA policy which read, an MSE was an ongoing process requiring continuing monitoring based on the patient's needs and must continue until the EMC was stabilized or the patient was appropriately transferred. Documentation of the MSE should have included the physical assessment and orders, intervention and treatments, the patient/fetus response to treatment, and continued monitoring.

iii. On 9/2/23 at 7:52 p.m., Patient #15 presented with vaginal bleeding. Patient #15 stated she was 20 weeks pregnant. A review of the patient's flowsheets revealed FHTs were not obtained until much later in the patient's visit when the provider performed an ultrasound. Further review of the provider's note read, the patient's bleeding was most likely due to a potential bladder infection, however, there was no evidence a visual exam was performed to confirm.

Additionally, there was no evidence an exam was performed to determine if the patient was in preterm labor.

B. Interviews revealed staff were unaware of how to complete an appropriate medical screening exam on pregnant individuals based on national standards.

i. On 12/20/23 at 4:40 p.m., an interview was conducted with Paramedic #1. Paramedic #1 stated when a pregnant person came into the ED, staff could use a hand-held Doppler to detect the fetal heart rate (FHR). Paramedic #1 further explained the facility ED had a tocodynamometer which was a device used to monitor FHR and contractions. Paramedic #1 explained that the tocodynamometer was not used in the department and was unaware of how or if staff were trained to use the machine.

ii. On 12/20/23 at 4:50 p.m., an interview was conducted with the ED charge registered nurse (RN) #2. RN #2 stated staff in the ED were able to utilize a Doppler to detect the FHR, however, no one was trained on how to utilize the tocodynamometer.

iii. On 12/20/23 at 1:09 p.m., an interview was conducted with emergency department provider (Provider) #3. Provider #3 stated when a pregnant person came to the ED, the patient would be brought back to an exam room and the provider would determine how far along the pregnancy was and if the patient had any additional concerns. Provider #3 further explained some providers in the ED would conduct a bedside ultrasound to observe the fetus however it was not standard practice. Provider #3 stated if a provider chose to conduct a bedside ultrasound, they would often only monitor the FHR on ultrasounds and would not conduct other FHR monitoring.

This was in contrast to the ACOG guidelines which read an assessment was to include an assessment of uterine contractions, the reason for presentation, the status of labor (presence of uterine contractions, vaginal bleeding, the status of membranes), the person's perception of fetal movement, and any high risk medical or obstetric conditions as identified by a review of history or the person's report.

iv. On 12/21/23 at 10:07 a.m., an interview was conducted with physician assistant (PA) #4. PA #4 stated when a pregnant person presented to the ED, the patient would be triaged by a nurse and a provider would potentially perform a bedside ultrasound. PA #4 explained an MSE for a pregnant person included an assessment, vital signs, and determining what the best treatment was. PA #4 further explained a fetal assessment would be completed based on a provider's comfort level of completing an ultrasound. PA #4 stated some concerns a pregnant person may have presented with included being in active labor or potentially a spontaneous abruption (when the placenta separated from the inner wall of the uterus before birth and could deprive the baby of oxygen). PA #4 stated if a patient and fetus were not provided an appropriate MSE, there was a risk of injury or death to either the mom, fetus, or both.

2. The facility failed to ensure patients who presented with suicidal ideation (SI, thoughts of ending one's life) were provided an MSE to determine if the patient had a psychiatric emergency condition.

A. Record Review

i. On 11/19/23 at 5:10 a.m., Patient #22 presented to the ED with law enforcement due to being suicidal. At 5:20 a.m., a Columbia Suicide Severity Rating Scale (C-SSRS, a scale used to assess a patient's suicide risk) was completed and determined the patient had a moderate risk for suicide. At 5:29 a.m., an order was placed for suicide precautions. A note written by Provider #12 read Patient #22 had been medically cleared and was evaluated by behavioral health.

There was no evidence in the medical record a full psychiatric examination had been completed to include the assessment of mood, judgment, and insight into the patient's thought process. Further, there was no indication the patient was further assessed for suicidal ideation to include the patient's intent and plan.

Further review of the medical record revealed contrasting discharge dispositions. Nursing documentation revealed the patient was discharged home, the behavioral health note read, the patient was accepted to a detox facility, and the medical provider documented the patient was admitted to an inpatient psychiatric program. Both the nursing note and behavioral health note were in contrast to the ED provider's note which read the patient was to be transferred to inpatient psychiatry.

There was no documentation revealing what facility or disposition Patient #22 was eventually discharged to.

This was in contrast to the MSE policy which read, the MSE documentation should include the QMP assessment and orders, intervention and treatment as well as documentation of continued monitoring.

ii. On 9/23/23 at 8:02 a.m., Patient #9 presented to the emergency department with SI. A review of the flowsheets revealed a C-SSRs was completed on the patient. The patient scored low on the C-SSR and did not have intent or a plan to commit suicide.

A review of Provider #12's note revealed the patient presented with a worsening duration of suicidal symptoms. The note further read the patient did not have an appropriate mood or affect, however, there was no evidence the provider conducted a more in-depth psychiatric evaluation to include the components of thought process, judgment, and insight as well as suicidal intent and plan.

A review of the patient's orders revealed Provider #12 placed an order for a behavioral health crisis evaluation. However, upon further review of the medical record, there was no evidence of a behavioral health evaluation or why an evaluation had not been conducted.

A brief behavioral health note read, the patient was agreeable to go to detox and had SI without a plan.

This was in contrast to the MSE policy which read, the MSE documentation should include the QMP assessment and orders, intervention and treatment as well as documentation of continued monitoring.

The review of Patient #9 and #22's medical records were in contrast to the Safety Precautions Suicide, Danger to Self, and Danger to Others in Non-behavioral Health Settings for Adults, Children, and Adolescents policy which read, a behavioral health consult should have been obtained for any patient believed to be a danger to self or others.

B. Interviews

i. On 12/19/23 at 9:45 a.m., an interview was conducted with RN #5. RN #5 stated when a patient with SI presented to the ED, they were placed in a room where harmful items were removed for patient safety. RN #5 stated when the patient was triaged, they were assessed for suicide. RN #5 explained the patient was then seen by a medical provider and assessed for an emergency medical condition. They further explained once the patient was cleared of a medical emergency, the patient was then typically evaluated by a behavioral health specialist (BHS) for a psychiatric emergency condition. RN #5 stated once this evaluation was completed, the providers would discuss what treatment the patient may need.

ii. On 12/21/23 at 10:07 a.m., an interview was conducted with PA #4. PA #4 stated when a patient came in with SI or a suicide attempt, the patient would be seen by a provider for medical clearance. Once the patient was deemed to be medically stable, the patient was then assessed by a BHS.

iii. On 12/26/23 at 10:41 a.m., an interview was conducted with behavioral health specialist (BHS) #6. BHS #6 stated when a patient came into the ED and had a behavioral health concern, the provider in the ED would typically order a behavioral health consult once the patient was medically stable. BHS #6 stated if a patient presented with SI, they were not always seen by a behavioral health specialist and it was up to the provider to order an assessment by a behavioral health specialist. BHS #6 stated when they were consulted to assess a patient, the assessment included a lengthy interview to include risk factors, warning signs, medical/psychiatric history, family history of mental illness, and any self-harming behaviors. BHS #6 stated if a patient was not assessed for a psychiatric emergency there was a risk the patient may not receive the appropriate treatment and could cause harm to themselves.

Based on interviews and record review, the facility failed to ensure patients were stable prior to transfer or discharge. Specifically, the facility failed to ensure a patient was monitored to ensure stabilization prior to discharge in one of one patient medical records reviewed where oral cardioversion (medications administered in order to convert an abnormal heart rhythm to a normal rhythm) was attempted (Patient #18). Additionally, the facility failed to ensure patients with suicidal ideation received stabilizing psychiatric treatment before discharge in two of three patients reviewed who presented with suicidal ideation (Patients #9 and #22). (Cross-reference A-2406).

Findings include:

Facility policy:

The EMTALA policy read, stabilizing treatment is defined as the treatment necessary to stabilize an EMC. Stable for transfer is defined as the determination of a physician or the QMP that the Patient's EMC is unresolved, but a Transfer may be made as no material deterioration of the Patient is likely and the receiving facility has the Capability of managing the Patient, including any foreseeable complications which might arise. Stable for Discharge is defined as the determination of a physician or QMP, within reasonable clinical confidence, that the Patient has reached a point where continued care, including diagnostic work-up and/or treatment, can be reasonably performed as an outpatient or later as an inpatient. A Patient may be Stable for Discharge even though the underlying medical condition persists.

The EMTALA policy further read, if the medical screening exam (MSE) demonstrates that an emergency medical condition (EMC) exists, the hospital will provide stabilizing treatment within the hospital's capabilities, even if the hospital must transfer the patient. A Patient with an EMC is stabilized when the physician/QMP determines that a. The Patient is Stable for Discharge (i.e., when, within reasonable clinical confidence, the physician or QMP determines that the Patient has reached the point where his/her continued care, including diagnostic work-up and/or treatment, could be reasonably performed as an outpatient or later as an inpatient); b. The Patient is Stable for Transfer (i.e., when the physician or QMP has determined, within reasonable clinical confidence, that the Patient is expected to leave the Hospital and be received at the second facility with no material deterioration of his/her medical condition and the treating physician reasonably believes the receiving facility has the capability to manage the Patient's medical condition and any reasonably foreseeable complications of that condition). With regard to a Psychiatric Emergency, stabilization means protecting the patient and preventing him/her from harming him/herself or others.

Discharge requirements: A patient will be discharged if, following the MSE, the physician or QMP determines that the patient does not have an EMC or is stable for discharge. Prior to discharge, the patient with an EMC is given a plan of care and discharge instructions, including a plan for appropriate follow-up care if necessary.

References:

The Flecainide drug reference read, Flecainide is contraindicated in patients with cardiogenic shock. Electrolyte disturbances, particularly potassium and sodium, can exacerbate or precipitate Flecainide cardiotoxicity. Electrolyte disturbances should be corrected before initiating therapy and monitored periodically throughout treatment. This drug should be considered a narrow therapeutic index (NTI) drug as small differences in dose or blood concentrations may lead to serious therapeutic failures or adverse drug reactions. Additional and/or more frequent monitoring should be done to ensure receipt of an effective dose while avoiding unnecessary toxicities. Flecainide should be used cautiously in patients with a history of CHF or myocardial dysfunction. Electrolyte disturbances (i.e., potassium, sodium) should be corrected before initiating Flecainide treatment. Monitoring of electrolytes (i.e., potassium, sodium) periodically has been recommended in high-risk patients in order to prevent Flecainide cardiotoxicity.

The report of the American College of Cardiology/American Heart Association (AHA) Task Force on Practice Guidelines and the Heart Rhythm Society Guidelines for the Management of Patients with Atrial Fibrillation (a-fib) provided Pharmacological Cardioversion Recommendations. Flecainide is useful for pharmacological cardioversion of a-fib provided contraindications to the selected drug are absent. Flecainide in addition to a beta blocker is reasonable to terminate a-fib outside of the hospital once this treatment has been observed to be safe in a monitored setting for selected patients. Antiarrhythmic drugs can be administered for attempted conversion of AF to sinus rhythm or to facilitate electrical cardioversion. Electrocardiographic monitoring should be continued for four hours after administration.

1. The facility failed to ensure a patient who received an antiarrhythmic medication (medication used to treat abnormal heart rhythms) was monitored and deemed stable for discharge.

A. A review of Patient #18's first emergency department visit medical record revealed a lack of continued monitoring and assessment to ensure the patient was stable before discharge.

i. On 4/22/23 at 2:36 a.m., Patient #18 arrived at the emergency department (ED) with the chief complaint of shortness of breath (SOB). At 2:46 a.m., Patient #18's vital signs were documented as follows: blood pressure (BP) of 123/109 (normal BP was 120/80), heart rate (HR) of 142 beats per minute (bpm) (normal heart rate was between 60-100), oxygen saturation of 93% (normal oxygen saturation was above 9, and a respiratory rate (RR) of 30 breaths per minute. Further assessment showed an electrocardiogram (EKG) was conducted and revealed the patient was in atrial fibrillation (an irregular and rapid heart rhythm).

ii. At 3:26 a.m., the provider note was entered and read, the patient came in without chest pain and had an increased SOB after the patient had stopped taking their metoprolol (a medication used to lower blood pressure and heart rate) five days earlier. The note further read there was a concern Patient #18 had possible fluid overload as well as congestive heart failure (CHF). The provider noted the plan was to provide the patient with Flecainide (a medication used to treat an irregular heart rhythm) to convert the patient's irregular heart rhythm to a regular heart rhythm.

iii. At 3:29 a.m., Patient #18 had the following lab results: a blood glucose level of 391 (normal glucose range was 70 milligrams per deciliter (mg/dL) to 100 mg/dL), a potassium level of 3.2 (normal potassium level was 3.6 to 5.2 millimoles per liter (mmol/L)), and a B-type natriuretic peptide (BNP) (a lab test conducted to detect heart failure) of 5025 picograms per milliliter (pg/ml) (a level greater than 1800 pg/ml indicated CHF).

iv. According to Patient #18's medication administration record (MAR), at 3:46 a.m. Patient #18 received 300 milligrams (mg) of Flecainide. At 4:08 a.m., Patient #18 received 10 units of insulin. Patient #18's blood glucose was rechecked at 5:12 a.m. and was 116. At 5:13 a.m., 5 mg of metoprolol was administered to the patient. There was no evidence Patient #18 was administered potassium in order to correct the low potassium level of 3.2.

The administration of Flecainide was in contrast to the Flecainide drug reference which read, electrolyte disturbances, particularly potassium, could precipitate Flecainide cardiotoxicity (heart damage from administration of certain medications). Electrolyte disturbances should have been corrected before initiating therapy and monitored periodically throughout treatment. Flecainide should have been used cautiously in patients with a history of CHF or myocardial dysfunction.

v. At 5:22 a.m., a provider note read, the patient's heart rhythm did not convert after the administration of Flecainide. Patient #18 was instructed to take her home dose of metoprolol as scheduled when they normally took medications after discharge.

vi. A review of the medical record revealed the patient was monitored on a heart monitor, however, there was no evidence an EKG was repeated after the administration of the Flecainide. At 5:43 a.m. the patient's vital signs were obtained and they were discharged home about two hours after the administration of Flecainide.

This was in contrast to the AHA guidelines for the management of patients with a-fib which read that electrocardiographic monitoring (ECG) should have been continued for four hours after administration of antiarrhythmic drugs.

B. A review of Patient #18's second emergency department visit medical record revealed Patient #18 returned to the emergency department approximately two hours after being discharged.

i. On 4/22/23 at 7:30 a.m., Patient #18 returned to the ED via ambulance. At the time of arrival, EMS reported the patient's blood pressure as 88/40.

ii. A review of Patient #18's flowsheets revealed at 7:41 a.m. their vital signs were a HR of 95, BP of 100/59, and RR of 22. At 7:58 a.m., Patient #18's lab results revealed their BNP had increased from 5025 pg/ml to 7364 pg/ml.

a. At 8:00 a.m., Patient #18 had a HR of 115 and a BP of 72/45. Shortly after, a one-liter intravenous (IV) bolus of normal saline (NS) fluid was administered to the patient.

b. At 8:30 a.m., Patient #18 required two liters (L) of oxygen. Additionally, an EKG was completed and revealed an a-fib heart rhythm.

c. At 8:50 a.m., Patient #18's oxygen requirement increased to 15 L, and a code blue (an announcement to staff indicating a patient was experiencing cardiac and respiratory arrest) was called. At 8:52 a.m., the patient was administered potassium chloride due to the potassium level of 3.1.

d. At 8:57 a.m., the patient was intubated (placement of a tube in the throat to assist with breathing) due to the concern the patient could lose their airway.

iii. A review of the provider's note revealed when Patient #18 returned home after her first visit, they took their normal morning dose of Lasix and metoprolol as instructed. The provider note further read the most recent EKG obtained was compared to the prior EKG obtained during the first ED visit and noted significant changes in the EKG. The provider further wrote they had consulted with a cardiologist. The cardiologist advised the change in the EKG could have been due to Flecainide toxicity.

iv. A review of the code blue record revealed cardiopulmonary resuscitation (CPR) was initiated. Additionally, sodium bicarbonate was administered. At 9:01 a.m., the code was terminated after a discussion with Patient #18's family, and the patient was pronounced deceased.

C. Interviews revealed monitoring was required for the administration of Flecainide.

i. On 12/26/23 at 10:57 a.m. an interview was conducted with the assistant director of pharmacy (Pharmacist) #7. Pharmacist #7 stated Flecainide was not often administered in the emergency department. Pharmacist #7 explained when Flecainide was administered, patients should have been monitored to confirm the cardiovert medication had converted the irregular rhythm to a regular rhythm. Pharmacist #7 stated Flecainide could cause detrimental effects and it was important to ensure electrolytes were not out of balance. Pharmacist #7 stated patients with a potassium level of 3.2 usually would receive potassium medication to increase the level.

The interview with Pharmacist #7 was in contrast to Patient #18's medical record review which revealed the patient did not receive potassium replacement prior to the administration of Flecainide. Additionally, there was no evidence an EKG had been repeated prior to the patient's discharge from the first ED visit.

ii. On 12/26/23 at 12:01 p.m., an interview was conducted with cardiologist provider (Provider) #8. Provider #8 stated if Flecainide was administered for cardioversion, it could have taken a few hours for the medication to be effective. Provider #8 stated it was important to monitor patients for a few hours after administration of Flecainide to ensure there were no adverse effects from the Flecainide. Provider #8 explained sometimes Flecainide toxicity could occur due to poor renal or hepatic function, leading to the body being unable to metabolize the medication.

2. The facility failed to ensure patients who presented with suicidal ideation (SI) were stable for discharge.

A. Medical records revealed psychiatric patients did not receive a medical screening exam for an emergency psychiatric condition, resulting in the potential for patients to not receive necessary stabilizing treatment.

i. On 11/19/23 at 5:10 a.m., Patient #22 presented to the ED with law enforcement due to being suicidal. At 5:20 a.m., a Columbia Suicide Severity Rating Scale (C-SSRS)(a scale used to assess a patient's suicide risk) was completed and determined the patient had a moderate risk for suicide. At 5:29 a.m., an order was placed for suicide precautions. A note written by Provider #12 read Patient #22 had been medically cleared and was evaluated by behavioral health.

There was no evidence in the medical record a behavioral health evaluation had been completed. In addition, there was no evidence in the medical record that stabilizing psychiatric treatment was provided based on the medical screening exam performed.

Further review of the medical record revealed contrasting discharge dispositions. Nursing documentation revealed the patient was discharged home, the behavioral health note read that the patient was accepted to a detox facility, and the medical provider documented the patient was admitted to an inpatient psychiatric program. There was no documentation revealing what facility or disposition Patient #22 was eventually discharged to.

ii. On 9/23/23 at 8:02 a.m., Patient #9 presented to the emergency department with SI. A review of the flowsheets revealed a C-SSRs was completed on the patient. The patient scored low on the C-SSR and did not have intent or a plan to commit suicide.

A review of the patient's orders revealed Provider #12 placed an order for a behavioral health crisis evaluation. However, upon further review of the medical record, there was no evidence of a behavioral health evaluation. The only documentation from the behavioral health staff read, the patient was agreeable to go to detox and had SI without a plan.

There was no evidence in the medical record that stabilizing psychiatric treatment was provided based on the medical screening exam performed.

B. Interviews

i. On 12/19/23 at 9:45 a.m., an interview was conducted with RN #5. RN #5 explained a patient who presented with a potential psychiatric emergency would be seen by a medical provider and assessed for an emergency medical condition. They further explained once the patient was cleared of a medical emergency, the patient was then typically evaluated by a behavioral health specialist (BHS) for a psychiatric emergency condition. Once this evaluation was completed, the providers would discuss what treatment the patient may need.

ii. On 12/26/23 at 10:41 a.m., an interview was conducted with behavioral health specialist (BHS) #6. BHS #6 stated when a patient came into the ED and had a behavioral health concern, the provider in the ED would typically order a behavioral health consult once the patient was medically stable. BHS #6 explained once they assessed a patient, there would be a conversation with the ED provider on what treatment the patient needed. BHS #6 stated if a patient did not receive psychiatric stabilization or treatment, there was a risk the patient may harm themselves or others.

This interview was in contrast with the medical record reviews of Patients #22 and #9 which showed no evidence of an assessment by a BHS or consultation with the ED provider on stabilizing treatments.