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Based on interviews, document review and during the course of a complaint investigation, it was determined the facility staff failed to comply with §489.24 - Special Responsibilities of Medicare Hospitals in Emergency Cases.

The findings include:

1. The facility staff failed to provide a Medical Screening Exam (MSE) to a patient who presented to the facility's helipad via a county EMS ambulance with plans to be transported by helicopter to a tertiary facility for a potential cardiac issue. The patient refused to fly and was subsequently transported by ground EMS ambulance.

2. The facility staff failed to ensure written bylaws and/or rules and regulations addressed which individuals were deemed qualified to complete the medical screening exams (MSEs).

Please see tag A-2406 for additional information.

Based on interviews, facility document review, emergency medical services documentation review, and during the course of a complaint investigation, it was determined the facility staff failed to 1. provide a medical screening exam (MSE) to a patient who initially arrived via ground ambulance to use the facility's helipad for air transport but refused air transport, requested to be assessed at the facility and then was transported by ground to a tertiary facility and 2. ensure written bylaws and/or rules and regulations addressed which individuals were deemed qualified to complete the medical screening exams (MSE's) to determine if patients presenting to the facility for emergency treatment had emergency medical conditions.

The findings were:

1. On 8/07/18 the survey team entered the free-standing emergency department referenced in the complaint (also referred to as the "facility" in this report). The team conducted the entrance conference with the emergency department (ED) director (Staff Member-SM #1) who was a registered nurse (RN). The director explained the facility functioned as a free-standing emergency department which was also an outpatient department of a larger hospital system located approximately 40 miles away. This free-standing ED also functioned under the same Centers for Medicare/Medicaid Services (CMS) certification number as the larger hospital (also referred to as the "recipient" facility in this report). The facility was open 24 hours/day and had a physician onsite at all times.

On 8/08/18, the facility's ED central log and diversion log were reviewed for the months of May, June, and July 2018. The ED log did not contain evidence of a patient meeting the description in the complaint. The facility's diversion log indicated there had been a limited diversion on 6/15/18 as well as other diversions for the time period reviewed. The ED director played back the facility's "med com" (radio communication between EMS - emergency medical service - and the facility) recordings from 6/15/18 for surveyors. Some of the recorded conversations from 6/15/18 were between a medic on a county EMS ambulance and the facility regarding a patient with potential cardiac concerns. The patient was requesting to be assessed at the facility. The ED director provided the transcripts of those conversations on 8/09/18. The transcripts read:

A. Call #1 on 6/15/18 at 8:22 p.m.:

"(Facility) Med Com: (Facility) Med Com go ahead.

(County) EMS: uh yes, this is (medic's name), (county) on Med Run 4 [sic]. I have a patient here that, .. they are requesting to go to (facility), but I told (patient) that I would have to call and consult you guys before I could transport (patient) because I believe it's a cardiac patient.

(Facility) Med Com: (County) we don't have Cath Lab here, so they would need to go to the most appropriate facility, the closest most appropriate.

(County) EMS: Okay, yeah, that is what I was assuming... cause (patient's) looking like (patient) had elevation. But they were... they wanted me to call and ask their... confirm.

(Facility) Med Com: Yes, that's correct, they would need to go to a Cath Lab facility.

(County) EMS: Alright, yeah, cause (patient's) got some elevation and uh, V1, V 2, so... Alright, I appreciate it.

(Facility) Med Com: Alright, (Facility) Med Com clear.

(County) EMS: All right thank you."

B. Call #2 on 6/15/18 at 8:42 p.m.:

"(Facility) Med Com: (Facility) Med Com, go ahead.

(County) EMS: uh, yes this is (medic name) with (county), I just talked to a female person there at Med Com, uh, about a patient that we were getting ready to fly out, from yall's [sic] helipad.

(Facility) Med Com: Yes, ma'am.

(County) EMS: I'm sorry.

(Facility) Med Com: Go ahead.

(County) EMS: Well, uh, it's a 76 year old (gender) and I was calling over here originally, was showing one millimeter of elevation in V1 and V2, and (patient) was hypotensive, now there is no elevation and (patient's) showing just a size rhythm [sic] with a bundle branch box [sic] which (patient) has a history of; (patient) did say (patient) had a bundle branch box [sic] to begin with and (patient's) vitals are now stable, uh, not really seeing any reason to fly (patient) and (patient) is pretty adamant about wanting to go to (facility). So, I thought I would call just to see what yall's [sic] thoughts were on that.

(Facility) Med Com: We're running it by the doctors now.

(County) EMS: OK

(Facility) Med Com: (County).

(County) EMS: Uh, yes, this is (medic name) on Med Run #4 [sic].

(Facility) Med Com: I spoke with (name of ED physician), (physician) says with a transient ST elevation, (patient) still is most appropriate for a facility that has a Cath Lab in case that were to return [sic]

(County) EMS: Ok, well I figured, so, I, just with (patient), (patient) stabilizing now I figured before we flew... did fly [sic] (patient) we would call and consult what we did.

The ED physician who was working at the facility the evening of 6/15/18 was interviewed via phone by two surveyors on 8/09/18 at 10:00 a.m. in the facility's consultation room. The physician's recollection was that initially, the county EMS crew called the facility with a possible STEMI (ST Elevation Myocardial Infarction) patient and that the EMS crew had already requested helicopter transport to a cath lab (for possible heart catheterization procedure). The physician understood the plan was for the ground ambulance to "rendezvous" with air transport at the facility's helipad. ["Rendezvous" meant the helicopter and ground ambulance meet at the facility's helipad to transfer a patient from ground ambulance to helicopter for air transport to tertiary/recipient facility]. The physician stated the charge nurse communicated the call related to a patient having ST elevation; the physician never spoke with the crew and added, "I never saw an EKG." (EKG - electrocardiogram - a record/display/tracing of a person's heartbeat). When asked if the physician knew the patient had requested to be assessed at the facility, the doctor said "I don't know that I was ever aware of the patient's request" to be assessed at the facility. The physician recalled the charge nurse communicating that the patient's EKG looked better and that the charge nurse had spoken with cath lab at the recipient facility. When asked about whether patients who present on the facility's property to rendezvous would have a medical screening exam (MSE), the physician stated that using the facility's helipad as a transfer place only was ok without an MSE unless the patient's condition deteriorated and needed to be stabilized or if the crew came in and advised the patient wanted to be seen. When asked if the expectation for a MSE would change when a patient who was expecting to rendezvous refused to fly, the physician said that if the patient was reliable to make their own decision, provide informed consent, there would be no difference in the expectation if they refused flight. If the patient required stabilization then yes, the patient would be stabilized. The physician stated that just a change in transportation method did not change the expectation of whether the patient would stop in the facility and reiterated that there was "no definitive management" provided at the facility.

Three (3) RNs who were working the evening of 6/15/18 were interviewed via phone, individually, by one (1) surveyor on 8/08/18 at 8:24 p.m. All three (SM #9, SM #10, SM #11) were working at the facility at the time of the phone interviews and all three recalled being involved in the Med Com communication. Their recollections of the Med Com calls matched with the transcripts written above. The RNs further commented:
· SM #9 who was the RN in charge on 6/15/18, did not see anyone from the ambulance crew or flight crew come in the facility and did not see the patient.
· SM #10 said he/she thought the ED physician was nearby when the Med Com calls came in and that everyone around could hear the communication. The nurse also received a call from someone, possibly dispatch, informing the facility the ground ambulance's arrival time was behind the flight crew's arrival time. The RN notified the ambulance medic the helicopter crew was on their way and shortly after that, SM #10 received a landline call from a cath lab nurse at the receiving facility asking about the patient. SM #10 conveyed to the cath lab nurse that there had been a 2nd call from the EMS crew saying the ST elevation resolved and the cath lab nurse said the patient would still need to come and the cath lab team would be waiting. SM #10 informed the surveyor the cath lab nurse's call was "new for me," that SM #10 had never received a call from a cath lab nurse inquiring about a patient prior to that call. The same RN recalled one of the county EMS providers coming into the facility to request a urinal and that provider said the patient really wanted to come to the free-standing ED. The county EMS provider told SM #10 they informed the patient they could not transport to the receiving facility. SM #10 did not know why the EMS crew could not transport to the receiving facility then said the EMS provider took the urinal and left. The nurse did not know for sure but wondered if the patient was requesting to be seen at the free-standing ED since the county EMS providers told the patient they could not transport to the receiving facility. An EMS provider from a different crew came into the facility, mentioned to SM #10 the patient may have simply had vasovagal syncope (slow heart rate and decreased blood pressure causing the patient to faint) versus ST elevation and told the RN the patient was refusing to fly. The nurse did not recall any other calls related to this patient.
· SM #11 stated the experience stuck out because it was the first time that particular county EMS had called in for a patient that SM #11 could recall. The RN was aware the patient requested to come to the facility and said he/she assumed the patient was flown to the recipient facility. SM #11 said EMS providers usually informed patients that they (EMS) were sorry, but they had to take patients to the closest appropriate facility. The RN noted that EMS agencies have their own protocols.

The EMT-intermediate from the county EMS (EMS A) ambulance agency, who was in charge of the patient from the scene and through transport to the facility helipad, was interviewed via telephone on 8/09/18 at 3:35 p.m. The EMT recalled informing the facility on the first Med Com call that the patient was requesting to be assessed at the free-standing ED and that at that time, the EMT agreed with the facility physician that the patient needed to be transported to a cardiac facility. The patient's condition improved during ground transport and the EMT informed the facility staff that the patient was no longer having ST elevation and was still requesting to be seen at the facility. The facility physician still wanted patient to be transferred to a facility with a cath lab. When asked what the EMT's experience with this facility had been, the EMT said that although there had only been a handful of times that he/she had transported to that facility, there had never been an issue with the facility staff not seeing patients for medical screening exams. The EMT stated the facility never said they were refusing to see the patient; they said the patient needed a cardiac facility. The medic denied seeing any facility employee coming to the patient and stated he/she had never stepped outside of the truck (ambulance). When asked, the EMT said the free-standing ED would be the closest facility from the patient's house.

The paramedic and the RN from the flight crew were interviewed via phone on 8/09/18. The paramedic was interviewed by the survey team at 1:05 p.m. The paramedic was employed by the health system that owned both the free-standing ED and the helicopter service. He/she thought they were only going to the facility property to use the landing zone but once the flight crew met the ambulance with the patient, the patient refused to fly and the flight crew convinced the patient to be transported by ground. The paramedic and flight nurse assessed the patient and found no neurologic or cardiac concerns and stated the 12-lead EKG looked "great." The paramedic stated that after obtaining permission from the ambulance supervisor, the paramedic and flight nurse took over the patient's care while transporting to the receiving facility. The paramedic denied having any experience at the free-standing ED where the facility's staff did not see a patient on their property and added that the staff at the facility was "very cautious if anything" and that this was the first time the paramedic could recall where a patient refused air transport. The flight RN was interviewed at 2:45 p.m. The RN's recollection matched the paramedic's summary of events. The RN recalled the patient's spouse wanting the patient assessed at the free-standing ED. The RN stated the flight crew used the facility's helipad from time-to-time as a safe rendezvous point, a safe landing zone. When asked about MSEs at the facility, the nurse stated there had not been problems, that they mostly rendezvous at that location on their way to somewhere else. The nurse felt he/she had been involved with that facility as a landing zone approximately a dozen times. The RN stated that with the patient being stable at the time of the planned rendezvous, the facility could have treated the patient there but that if it was a cardiac episode, treating the patient at the facility versus transporting the patient to a tertiary facility right away could have delayed the necessary treatment.

The facility's medical director was interviewed in person by two surveyors on 8/09/18 at 9:19 a.m. in the facility's consultation room. The physician said "this morning," he/she had discussed this case with the ED physician who worked last night at the facility and who was also the medical director of the flight service. The medical director said this case was unique and that it sounded like the patient was stable and EMS had not requested the facility receive the patient for evaluation. The facility was not notified of the change of transportation. The facility's medical director said the providers at the facility would never refuse to see someone. If any patient was expected to rendezvous at the helipad and the patient's condition deteriorated prior to the flight, the facility staff would expect the patient to be treated at the facility's ED. The physician gave examples of occasions when patients' conditions needed stabilization before flight. When asked how STEMI patients were handled when EMS called to say they were en route to the facility, the physician stated it was best to get the patient out within 10 minutes, that if the helicopter was at the facility, there'd be no delay, the patient would automatically fly to a tertiary care facility expecting the patient would need cath lab services. EMS personnel can call the cath lab and the helicopter themselves. If the patient arrived to the facility before the helicopter, the expectation was the patient would be brought into the facility.

The facility's ED director and the facility's director of accreditation and licensure were interviewed in person in the facility's conference room on 8/08/18 at 4:35 p.m. The facility director stated he/she had spoken with employees and referenced a shift report (the director provided that shift report to the survey team) from 6/15/18 in which the charge nurse had documented the above described rendezvous. The report noted the county EMS called Med Com regarding a patient with chest pain requesting to come to facility. The patient had ST elevation in leads V1 and V2 and EMS thought the facility would not be an appropriate facility for ST elevation but rather go to the closest facility with a cath lab. The EMS brought the patient to helipad to transport to recipient hospital for cath lab. The ED director said they now know the patient didn't want to fly so they ended up transporting the patient by ground ambulance. The director said he/she would now feel that once the patient refused the helicopter, he/she would see the situation as an ambulance showing up with a patient. The ED director had never had both an ambulance and helicopter show up and the patient not go via air unless the patient's condition deteriorated and needed stabilization. Typically, the helicopter was called by EMS, they show up and get the patient and go. The fact the patient did not go on the helicopter was unusual. When asked whether the expectation would change with the patient requesting to be seen at the facility, the director stated that the EMS agency staff decides where to take the patient related to their protocols. The director said the goal for a cardiac patient would be to have a PCI (percutaneous coronary intervention - cath lab) within 90 minutes. The protocol for STEMI if the patient was at the facility would be to send the patient by ground if a ground ambulance was there because that would be faster than launching the air ambulance. The facility usually had two (2) ground ambulances available 24 hours/day with staggered on and off times. Even if diversion was active, if a patient showed up in ambulance or otherwise, they would be seen and evaluated. The facility's director of accreditation and licensure said the facility's employees on 6/15/18 thought the flight had left with the patient and did not realize the patient had gone via ground transport.

The patient's medical record from the recipient hospital's ED was reviewed by one surveyor on 8/08/18. The ED record showed the patient's date of service as 6/15/18 at 10:07 p.m. The chief complaint was documented as "syncope" and after examination and diagnostic studies the patient's disposition was listed as an ED observation bed which was ready on 6/16/18 at 2:02 a.m.

The facility's "Acute STEMI Protocol" which was revised 10/2015 was provided and reviewed on 8/09/18. The protocol provided phone numbers to call for notification of emergent transfer and notification of on call cardiologist as well as medications to administer. The protocol also read in part, "If patient within 45 minutes of (recipient) hospital, all attempts should be made to bypass (facility ED) and come straight to (recipient) hospital." And, "Goals: DIDO (door-in/door-out) time<45 minutes and a FMC [first medical contact] to balloon time<90 minutes."

Three (3) of The (Locale) Emergency Medical Services Council policies/protocols were provided and reviewed. The county EMS ambulance agency referred to in the report was a part of this council. The "Ambulance Patient Destination" policy read in part, "1. All ambulance patients (resulting from requests for emergency assistance that result in transport) will normally be transported to the closest appropriate hospital emergency department unless redirected by the Medical Control Physician. The closest appropriate hospital is defined as the hospital closest to the location of the patient that can provide the level of care needed by the patient. The Medical Control Physician is defined as the attending emergency department physician at the hospital contacted by radio, cellular phone, or other means by the prehospital provider attending to the patient to be transported. 2. Stable patients may be transported to the patient's destination of choice if allowed by local EMS agency policies and available resources.... 4. Individual EMS agencies are responsible for determining operational policies related to the most effective ambulance deployment and utilization patterns. This may include policies allowing transport of stable patients to hospitals of a patient's choice..."

The facility's policy titled, "Medical Screening and Transfer EMTALA Policy - LGH, VBH, GMC" (ID Number: CLIN 08.16.31)approved 6/06/18 read in part, "C. WHEN AND WHERE EMTALA APPLIES 1. EMTALA (and this Policy) applies when: b. a person is present on Hospital Property and requests (or has a request made on his or her behalf for) emergency medical treatment. d. is in an ambulance not owned by the Hospital but which has traveled on to Hospital Property. Note: Centra does not have an EMTALA obligation in cases where local ambulance services/EMS are only on Centra property for the purpose of using Centra's helipad as the point of transit to a tertiary hospital for an individual who has had an MSE performed prior to transfer to the helipad (as opposed to a patient being brought to Centra for treatment). If however, while at the helipad, the individual's condition deteriorates, Centra must provide another MSE and stabilizing treatment within its capacity if requested by medical personnel accompanying the individual. 5. For EMTALA to apply, Hospital personnel must be aware of the individual's presence and observe the appearance, condition, or behavior, or both of that person. This applies to presentations at off-campus DEDs. E. MEDICAL SCREENING EXAMINATION 1. Who Must Be Screened. All persons who present to a DED and request medical treatment must be provided an appropriate MSE to determine whether or not the patient has an EMC..."

2. The entrance conference was conducted by the survey team on the afternoon of 8/7/18. The facility's freestanding emergency department director (Staff Member (SM) #1) was in attendance. SM #1 was asked for the facility's by-laws and/or rules and regulations that addressed who could complete medical screening exams (MSEs).

On 8/8/18 at 10:10 a.m., SM #2 (Director of Accreditation and Licensure) provided the survey team with a policy entitled "MEDICAL SCREENING AND TRANSFER EMTALA POLICY" (this policy had an approved date of 6/6/18). This policy identified who were allowed to complete the MSEs. The survey team was informed the bylaws and/or rules and regulations might not address who were allowed to complete the MSEs.

On 8/9/18 at 12:30 p.m., SM #8 (an accreditation and licensure specialist) provided the survey team with a document entitled "Centra Medical Staff Bylaws" (this document had an approval date of 5/29/17). The following section was presented to the surveyor to address who were allowed to complete the MSEs: "By submitting an application for Staff appointment and/or requesting Privileges, the applicant signifies agreement to fulfill the following obligations of holding Staff appointment and/or Privileges. The applicant shall agree to: ... Abide by these Bylaws, the Policies, Rules and Regulations, and all other rules, policies and procedures, guidelines, and other requirements of the Medical Staff and the Hospital".

On 8/9/18 at 1:25 p.m., SM #6 (Assistant General Counsel) reported the facility's bylaws and/or rules and regulations do not identify who is qualified to complete the MSEs.