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9901 MEDICAL CENTER DRIVE

ROCKVILLE, MD 20850

COMPLIANCE WITH 489.24

Tag No.: A2400

Based on a review of 22 patient records, emergency department logs, hospital policies and procedures, hospital personnel files, training materials, interviews with staff, as well as a review of video surveillance footage, it was determined that the hospital failed to ensure compliance with 42 CFR 489.20 and 42 CFR 489.24, as evidenced by:

1) Failure to develop and provide adequate training related to the hospital's obligations under the Emergency Medical Treatment and Active Labor Act (EMTALA) to physicians and qualified medical personnel (QMP).
2) Failure to ensure that Emergency Department staff were compliant with the hospital's annual EMTALA education requirement.
3) Failure to ensure that each patient seeking medical treatment was included on the Emergency Department Central Log. Cross-reference to tag A - 2405.
4) Failure to ensure that each patient seeking medical treatment received a medical screening exam. Cross-reference to tag A - 2406.
5) Failure to ensure that ED physicians completed all sections of a required signed certification at the time of a patient transfer and discuss the risks and benefits of a transfer with patients. Cross-reference to tag A - 2409.

The findings include:

1) On 03/31/2022, day #1 of the survey, the surveyors made a request to review the EMTALA training and education materials for physicians and other qualified medical personnel (QMP) who were authorized to perform a medical screening examination in the hospital's Emergency Departments. On 04/01/2022, the hospital provided a document titled "Adventist Health Care Medical Staff and Allied Health Professional/ Advance Practitioner Orientation." This document consisted of 159 pages, with 3 out of 159 pages dedicated to the hospital obligations under the Emergency Medical Treatment and Labor Act (EMTALA). Review of the EMTALA content determined that there was no information/education provided to the hospital QMPs pertaining to the following requirements of EMTALA:
- §489.20(m) - the requirement to report suspected incidences of individuals with an Emergency Medical Condition transferred in violation of §489.24(e)
- §489.20(r)(2); §489.24(j) - the required availability of On-Call physicians
- §489.24(e)(3) - Whistleblower Protections, and
- §489.24(f) - Recipient Hospital Responsibilities.

The absence of these provisions from the provider training prohibits the ability of the hospital QMPs to comply with the above requirements and recognize potential EMTALA violations. The lack of QMP's understanding of their obligations under EMTALA was evident during the interviews conducted with the ED staff throughout the survey. Specifically, on 04/04/2022, 2 of 3 interviewed QMPs were unable to verbalize awareness of the above provisions.

2) Review of hospital policies, Medical Staff Bylaws and Rules and Regulations, personnel files, and interviews with staff determined that the hospital failed to ensure that its Emergency Department staff, including QMPs and nursing staff, were compliant with the hospital's annual EMTALA education requirement.

On 04/04/22, the surveyors interviewed the Supervisor of the Medical Staff Office. During the interview, the surveyors learned that the hospital monitored competencies of its QMPs through an annual review of specific hospital policies and an electronic attestation of review completion. The attestation document included the requirement for providers to review a total of 9 documents/policies/agreements annually, one of which was the Medical Staff Allied Health Professional / Advance Practitioner Orientation where the EMTALA training resided. These items would be first completed at the time of initial appointment of a provider and annually thereafter.

The surveyors conducted a review of 4 QMP personnel files to evaluate compliance with the EMTALA education. Review determined the following:

Physician or Qualified Medical Profession # 1's (QMP1) most recent annual attestation of the EMTALA education was completed in January 2019. The hospital failed to ensure annual EMTALA training for QMP1 for 2020, 2021, and 2022.

Physician or Qualified Medical Profession # 2's (QMP2) most recent annual attestation of the EMTALA education was completed in March 2020. The hospital failed to ensure annual EMTALA training for QMP2 for 2021 and 2022.

Physician or Qualified Medical Profession # 3 (QMP3) most recent annual attestation of the EMTALA education was completed in September 2020. The hospital failed to ensure annual EMTALA training for QMP3 for 2021.

Physician or Qualified Medical Profession # 4 (QMP4) most recent annual attestation of educational compliance specifically for EMTALA education was July 2021. QMP4 was in compliance with annual EMTALA training requirements.

3 out of 4 QMPs reviewed were not current on the required annual EMTALA education.

On 04/01/2022 at approximately 11:00 am, the surveyors interviewed the Assistant Senior Vice President of Human Resources. The surveyor learned during the interview that the hospital's process for monitoring the training compliance of its nursing staff, including the EMTALA training, was through the digital learning modules/competencies assigned to staff annually. The EMTALA training was listed as a Condition Of Employment (mandatory) course.

Review of the 6 ED nursing personnel files on 04/01/2022 found that 3 of 6 RNs had not completed the required annual education, including the EMTALA education. Cross-reference to tag A-0398.

Registered Nurse RN#1's (RN1) date of hire was February 2018; the most recent annual competencies were dated 2018. There were no 2019, 2020, 2021, and 2022 competencies present in the employee file, including the EMTALA Training.

Registered Nurse RN#2's (RN2) date of hire was November 2021. There were no completed competencies on file for RN2. RN2's transcript showed that the courses were assigned on March 17, 2022, but none were completed.

Registered Nurse RN#3's (RN3) date of hire was November 2021. RN3 completed some annual competences but lacked the EMTALA education.

Subsequent interviews with the six members of the ED nursing staff determined that none of the six interviewed staff were able to speak to all the EMTALA requirements.

The hospital's failure to monitor compliance of its staff with the mandatory EMTALA education resulted in the staff's lack of awareness of the hospital's obligations under EMTALA and potentially contributed to the EMTALA violations identified during this survey.

3) The hospital failed to provide a medical screening examination to a patient (Patient #21) who presented to one of its dedicated Emergency Departments in late March 2022 seeking medical treatment. Cross-reference to tag A-2406.

4) The hospital failed to maintain an accurate and complete Central Log of all patients who presented to its dedicated Emergency Departments seeking medical evaluation and treatment. Cross-reference to tag A-2405.

5) The hospital failed to ensure that its ED physicians completed all sections of a required signed certification at the time of a patient transfer which discussed risks and benefits of a transfer. Cross-reference to tag A-2409

EMERGENCY ROOM LOG

Tag No.: A2405

Based on review of the hospital ' s central logs, policies and procedures, video surveillance footage, and interviews with staff, it was determined that the hospital failed to maintain a central log that captured all individuals who presented on hospital grounds seeking emergency evaluation and treatment. The hospital staff failed to document presentation of at least one patient, Patient #21, who was brought to the hospital's off-campus Emergency Department in late March 2022 by a county-operated ambulance.

The findings include:

Hospital #1 has 2 dedicated Emergency Departments: The Main Emergency Department (located on the campus of the hospital), referred to as the Main ED, and an off-campus Emergency Department, referred to as the Emergency Center (EC). The EC is located approximately 9 miles from the main hospital campus. Both Emergency Departments share the same communication radio line with the county's Emergency Medical Services (EMS).

Based on a report of a potential EMTALA violation, the surveyors interviewed the EMS driver of the county-operated ambulance who transported Patient #21 (P21) to the EC in late March 2022. The driver reported that, on the day in question, the ambulance was dispatched to a motel for a sick person call. The EMS personnel arrived on the scene to find Patient #21 (P21) who was a 25+ year old with a chief complaint of all over body aches. The EMS escorted P21 to the ambulance and the decision was made to transport the patient to the nearest emergency department, the EC.

The EMS driver reported that 3 radio communications were attempted to the EC without answer while the ambulance was driving towards the EC. These communications are part of the EMS protocols: they inform hospital emergency departments of the ambulance's estimated arrival time and provide details about the incoming patient's symptoms and priority. Following unanswered calls to the EC, the EMS driver sent a communication to the Main ED charge nurse with the request to get the EC on the line and alert that the ambulance arrival was impending.

The ambulance reportedly arrived at the EC several minutes later and the EMS driver went into the EC to get a wheelchair for P21, while the second EMS provider was attending to P21 in the back of the ambulance. Per the EMS driver, certain patients with non-life-threatening conditions may be taken by the EMS to the ED's waiting room to be registered and complete the hand-off of care to the hospital staff. The EMS driver stated that before he/she was able to get the wheelchair for the patient, he/she encountered a hospital nurse who told the EMS driver that the ambulance and the patient could not be there due to the EC handling two sick patients. The nurse additionally stated that the ED physician had said the ambulance could not be there. Per the EMS driver, there were additional words exchanged with the nurse about the situation and the EMS driver eventually walked out of the EC with the impression that the patient would not be examined by the EC staff. The EMS driver stated he/she did not see or speak with the physician or qualified medical Professional (QMP) while in the EC. The EMS driver re-entered the ambulance, consulted with the second EMS provider, and they decided to take the patient to another area hospital (Hospital #2). The patient was transported to Hospital #2 without an incident, and P21 was transferred into the care of Hospital #2's ED staff.


On 03/31/2022 at approximately 11:00 am, the surveyors reviewed the Emergency Center's (EC) Central log for the day in question which showed that 8 patients were receiving care at the EC approximately 1 hour prior to the arrival of the ambulance and P21. These eight patients included: a child in respiratory distress and requiring a transfer to a higher level of care, an adult with a suspected heart attack and requiring a transfer to a higher level of care, two additional adult patients requiring higher level of care transfers, and 4 other patients waiting to be seen. The EC staffing at this time included one Physician or Qualified Medical Professional, one Charge Nurse, one ED technician, and two registered nurses (RN).

The surveyors did not find P21 listed on the hospital's Central Log.

On 03/31/22 at 2:35 pm, the surveyors reviewed the video surveillance footage of the ambulance bay are of the EC on the day in question in the presence of the hospital's Security Manager. The following observations were made:

- At 4:45 a.m., a county operated ambulance pulled into the ambulance bay of the Emergency Center (EC). The EMS driver got out
of the ambulance and walked into the Emergency Center.
- There was no visualization of the EMS driver for approximately 10 minutes, while in the EC.
- At 4:55 a.m., the EMS driver exited the EC and got back into the county operated ambulance. The ambulance drove off at 4:56 a.m.
- Patient #21 (P21) was not offloaded or brought into the EC.
- No EC staff came out to the ambulance.
- There was no internal video surveillance available for this incident, as the hospital did not have an internal camera view of the ambulance entrance.

Based on the information gathered, the surveyors established that P21 presented on the hospital grounds via an ambulance seeking an emergency evaluation and treatment but was not registered or evaluated (cross-reference to tag A-2406.) The hospital staff also failed to document the patient and their disposition on the ED Central Log.

MEDICAL SCREENING EXAM

Tag No.: A2406

Based on the review of 22 medical records, the Emergency Department Central Log, interviews with staff, review of video surveillance footage, and other pertinent documentation, it was determined that the hospital (Hospital #1) failed to perform a medical screening examination for Patient #21 who presented to the hospital's off-campus Emergency Department in late March 2022.

The findings include:

Hospital #1 has 2 dedicated Emergency Departments: The Main Emergency Department (located on the campus of the hospital), referred to as the Main ED, and an off-campus Emergency Department, referred to as the Emergency Center (EC). The EC is located approximately 9 miles from the main hospital campus. Both Emergency Departments share the same communication radio line with the county's Emergency Medical Services (EMS).

Based on the report of a potential EMTALA violation, the surveyors interviewed the EMS driver of the county-operated ambulance who transported Patient #21 (P21) to the EC in late March 2022. The driver reported that, on the day in question, the ambulance was dispatched to a motel for a sick person call. The EMS personnel arrived on the scene to find Patient #21 (P21) who was a 25+ year old with a chief complaint of all over body aches. The EMS escorted P21 to the ambulance and the decision was made to transport the patient to the nearest emergency department, the EC.

The EMS driver reported that 3 radio communications were attempted to the EC without answer while the ambulance was driving towards the EC. These communications are part of the EMS protocols: they inform hospital emergency departments of the ambulance's estimated arrival time and provide details about the incoming patient's symptoms and priority. Following unanswered calls to the EC, the EMS driver sent a communication to the Main ED charge nurse with the request to get the EC on the line and alert that the ambulance arrival was impending.

The ambulance reportedly arrived at the EC several minutes later and the EMS driver went into the EC to get a wheelchair for P21, while the second EMS provider was attending to P21 in the back of the ambulance. Per the EMS driver, certain patients with non-life-threatening conditions may be taken by the EMS to the ED's waiting room to be registered and complete the hand-off of care to the hospital staff. The EMS driver stated that before he/she was able to get the wheelchair for the patient, he/she encountered a hospital nurse who told the EMS driver that the ambulance and the patient could not be there due to the EC handling two sick patients. The nurse additionally stated that the ED physician had said the ambulance could not be there. Per the EMS driver, there were additional words exchanged with the nurse about the situation and the EMS driver eventually walked out of the EC with the impression that the patient would not be examined by the EC staff. The EMS driver stated he/she did not see or speak with the physician or qualified medical Professional (QMP) while in the EC. The EMS driver re-entered the ambulance, consulted with the second EMS provider, and they decided to take the patient to another area hospital (Hospital #2). The patient was transported to Hospital #2 without an incident, and P21 was transferred into the care of Hospital #2's ED staff.

During the interview, the EMS driver also reported that the Maryland EMS and Maryland hospitals used a statewide alert tracking system which allowed staff from hospital emergency departments across the state to communicate to EMS the availability of ED beds and critical resources or lack of thereof. This system could be used to alert EMS of an ED experiencing a temporary overwhelming patient overload such that certain patients may not be managed safely. When making the transport decision, the EMS staff would take the alerts into the consideration to choose the safest destination based on the patient needs and the availability of resources. The EMS driver stated that at the time of P21's transport, the EC did not have any alerts posted that would suggest that a diversion to another hospital was needed.

On 03/31/2022 at approximately 11:00 am, the surveyors reviewed the Emergency Center's (EC) Central log for the day in question which showed that 8 patients were receiving care at the EC approximately 1 hour prior to the arrival of the ambulance and P21. These eight patients included: a child in respiratory distress and requiring a transfer to a higher level of care, an adult with a suspected heart attack and requiring a transfer to a higher level of care, two additional adult patients requiring higher level of care transfers, and 4 other patients waiting to be seen. The EC staffing at this time included one Physician or Qualified Medical Professional, one Charge Nurse, one ED technician, and two registered nurses (RN).

The surveyors did not find P21 listed on the hospital's Central Log.

On 03/31/22 at 2:35 pm, the surveyors reviewed the video surveillance footage of the ambulance bay are of the EC on the day in question in the presence of the hospital's Security Manager. The following observations were made:

- At 4:45 a.m., a county operated ambulance pulled into the ambulance bay of the Emergency Center (EC). The EMS driver got out of the ambulance and walked into the Emergency Center.
- There was no visualization of the EMS driver for approximately 10 minutes, while in the EC.
- At 4:55 a.m., the EMS driver exited the EC and got back into the county operated ambulance. The ambulance drove off at 4:56 a.m.
- Patient #21 (P21) was not offloaded or brought into the EC.
- No EC staff came out to the ambulance.
- There was no internal video surveillance available for this incident, as the hospital did not have an internal camera view of the ambulance entrance.

The surveyors interviewed the hospital nursing staff who were on shift at the Main ED and in the EC during the time frame of the events described above. The staff interviewed included: the EC Charged Nurse (CN1), the Main ED's Charge Nurse #2 (CN2), and the EC Registered Nurse #2 (RN2).

The surveyors learned during the interviews that both locations shared the same EMS communication radio line. This meant that the Main ED staff and the EC staff could hear each other's radio calls with EMS.

In separate interviews, both CN1 and CN2 reported that they had a telephone discussion about the unanswered EMS communications heard over the EMS radio and reached an agreement to divert the ambulance en route to the EC to the Main ED due to the volume and acuity of patients at the EC. CN2 attempted to return communications with EMS via radio to inform the EMS that the patient should be diverted to the Main ED and not brought to the EC.

On 04/04/2022, the surveyors reviewed the audio recording of the radio communication between the EMS driver, the EC, and the Main ED during the time frame of the incident. The following could be heard on the recording:

- The EMS driver requested to speak with the EC 3 times.
- The EMS driver requested the Main ED to contact the EC via telephone and alert them of the ambulance en route. The description of the patient was also provided to the Main ED and the estimated arrival time of 5 minutes.
- The Main ED staff responded to the EMS driver approximately 5 seconds later: "Germantown is diverting to Shady Grove."
- The EMS driver stated "Germantown" and the recording ended. There was no formal acknowledgment that the EMS driver heard and understood the message from the Main ED.

The surveyors asked CN1 to describe to the interaction between the EC and the EMS staff while P21 was on the hospital grounds. CN1 stated that he/she was in a patient room taking care of an ill child and did not hear the EMS radio go off. CN1 answered the call from the Main ED while CN1 and the ED provider were attending to the child and the ED provider stated that the EMS should be diverted to the Main ED, prior to the ambulance's arrival to the EC. CN1 reported he/she was not aware of the physical arrival or departure of the ambulance and did not communicate directly with the EMS inside the EC.

The interview with Registered Nurse #2 (RN) determined that RN2 was assigned to an adult patient awaiting a transfer at the time of the incident. RN2 recalled seeing the EMS staff at the Unit Support Coordinator's desk and assuming this was the transport for RN2's patient. RN2 stated that the ED Technician #1 (EDT1) and the EMS staff were arguing that the ambulance was not to be there and was to be diverted to the Main ED. RN2 stated that he/she told the EMS to hold on and went to alert CN1 of the ambulance arrival, while CN1 and the ED physician were in the room attending to the sick child. RN2 stated that CN1 yelled back to RN2 from the room that the EMS needed to go to the Main ED. RN2 denied telling the EMS to leave the ED. RN2 did not recall seeing CN1 speaking to the EMS staff directly.

Based on the information gathered, the hospital staff interaction with the EMS staff unduly discouraged the EMS staff to transfer the care for P21 to the EC staff; as result, the hospital failed to ensure that P21 who presented on the hospital grounds seeking evaluation and treatment received a medical screening exam.

APPROPRIATE TRANSFER

Tag No.: A2409

Based on the review of the hospital policy and 6 medical records of patients transferred out of the hospital's Emergency Department, it was determined that the hospital failed to ensure that its ED physicians completed all sections of a required signed certification at the time of transfer for 3 out of 6 patients reviewed.

The findings include:

The surveyor reviewed the policy titled "EMTALA."

Section "E. Patient Transfers" of the policy stated:

2. Informed Consent: Where the transfer is medically recommended, the Hospital will notify the individual or, where applicable, the individual's LRP, both orally and in writing of the recommended transfer and the reasons thereof ...An acknowledgement by the individual or the LRP of such notification and consent to the transfer should be included on the 'Transfer Summary Form.' Where the individual is suffering from an emergency medical condition which has not been stabilized, the 'Transfer Summary Form' must also include the ER (Emergency Room) Physician/Labor and Delivery RN's (Registered Nurse) written certification that the benefits of the transfer outweigh the risks ...5. Copies of Medical Records/Consents/Certification: The Hospital will send the receiving facility copies of all pertinent medical records available at the time of transfer, including: a. history; b. records related to the individual's emergency medical condition; c. observations of signs or symptoms; d. preliminary diagnosis; e. results of diagnostic studies or telephone reports of the studies; f. treatment provided; g. results of any tests; and h. a copy of the informed written request or certification and consent to transfer.


Review of 6 medical records of patients transferred from the hospital's off-campus Emergency Department determined that:

1.Patient #3 (P3) was a 15+ month old who presented with a parent to the off-campus Emergency Department (ED) with a chief complaint of difficulty breathing and a fever for 3 days. Interventions provided to the patient while in the ED included: labs, fluids, chest x-ray, antibiotic therapy. The child's condition continued to worsen requiring high flow oxygen (humidified and heated oxygen therapy delivered at a higher rate than normal). The ED providers considered intubating the patient, but the decision was ultimately made to transfer the patient to a specialized hospital for a higher level of care.

The receiving hospital accepted P3, and the patient was transferred within approximately 3 hours of the arrival to the ED. There was no documentation found in the patient's medical record or in the "Inter Agency Transfer Form" describing what information was sent with the patient at the time of the transfer. Additionally, the following sections on the "Inter Agency Transfer Form" were blank/not completed by the hospital staff on the first page of the form:

- Physician Attestation, which should have included: description of whether the patient was stable or not at the time of the transfer; description of risks and benefits associated with the transfer; and the mode of transportation for P3; and
- Instructions for Transportation, which would describe the level of providers needed to accompany the patient.

The second page of the transfer form, dedicated to the patient or representative consent and signatures, was not scanned into the record. As a result, it was also unclear if the parent(s) consented to the P3 being transferred. The surveyor was not able to locate any of the above information in any other parts of the patient's medical record.


2. Patient #16 (P16) was an 80 + year old patient who presented to the off-campus Emergency Department (ED) with complaints of shortness of breath and a positive COVID-19 test. P16 had a low pulse oximetry rate (measurement of the oxygen level in the blood) and subsequently required high flow oxygen (humidified and heated oxygen therapy delivered at a higher rate than normal).

Review of the record determined that P16 was ultimately transferred from this ED to another specialized hospital for a higher level of care. There was no documentation found in the patient's medical record or in the "Inter Agency Transfer Form" describing what information was sent with the patient at the time of the transfer. Additionally, the following section on the "Inter Agency Transfer Form" was incomplete by the hospital staff on the first page of the form: Physician Attestation, which should have included: description of whether the patient was stable or not at the time of the transfer and description of risks and benefits associated with the transfer.

The second page of the transfer form, dedicated to the patient consent signatures, was blank. As a result, it was also unclear if P16 consented to being transferred. The surveyor was not able to locate any of the above information in any other parts of the patient's medical record.


3. Patient #17 (P17) was a 50 + year old patient who presented to the off-campus Emergency Department (ED) with intermittent nosebleeds. It was determined that P17's blood pressure was elevated, and they required a higher level of inpatient care.

The patient was transferred to a higher level of care approximately 3 hours after presentation to the ED. Review of the "Inter Agency Transfer Form" determined that the ED staff did not document what information was sent with the patient at the time of the transfer. Also not documented on the "Inter Agency Transfer Form was the risk/benefits section. The surveyor could not locate this information in any other parts of the patient's medical record.

It should be noted that no "Transfer Summary Forms" were found in any of the 3 medical records as referenced in the hospital policy. The transfer form in the medical records of those who were transferred were titled "Inter Agency Transfer Form."