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217 SOUTH THIRD STREET

DANVILLE, KY 40422

COMPLIANCE WITH 489.24

Tag No.: A2400

Based on interview, record review, review of Facility #1's policies, medical staff by-laws, and review of Patient #1's medical record from Facility #2, it was determined the the on-call physician failed to present to the Emergency Department (ED), when requested, to evaluate and treat Patient #1, one (1) of twenty-five (25) sampled patients.

Cross Refer to the findings in Tag A-2404.

ON CALL PHYSICIANS

Tag No.: A2404

Based on interview, record review, and review of Facility #1's policies, and medical staff by-laws, it was determined the facility failed to comply with 42 CFR 489.24(j)(1) related to an On Call General Surgery Physician declining to provide a consult for a patient with an Emergency Medical Condition (EMC), for one (1) of twenty-five (25) sampled patients, Patient #1.

The findings include:

Review of the facility's policy #EMHSWH010, approval date 05/24/2022, titled "Treatment and Transfer of Individuals Who Request Emergency Medical Services", revealed On-call Physicians would respond to the emergency department (ED) within time if they were requested to do so. In this case, the response time for the General Surgeon to respond to the request to consult Patient #1 was thirty (30) minutes.

Review of the Facility's Policy #EMRMC0MS023, approval date 09/2023, revealed all Active Staff members were responsible for coverage for their in-patients and for those patients that presented to the ED as a condition of maintaining their Active Medical Staff membership and Clinical privileges.

Review of the facility's By-Laws, dated 09/28/2022, revealed if a STAT (immediate) request was made to the on-call Physician, the response time was expected to be as soon as the requested Physician could arrive to the facility. Further review of the By-Laws revealed if the request was not STAT, the on-call Physician response time was thirty (30) minutes.

Review of General Surgeon (GS) #1's surgical privileges, dated 05/25/2022, revealed GS #1 had privileges for extremity amputations through the next review period of April 30, 2024.

Review of Patient #1's clinical record from Facility #1 revealed he/she presented to the emergency department (ED) on 08/23/2023 from his/her primary care physician's (PCP) office, as a walk-in, at 10:10 AM. The Chief Complaint was an infected foot. Review of the physical exam (PE) revealed Patient #1 was thin, with a chronically ill appearance. He/she was lethargic but was oriented to person, place, and time. Continued review of the PE revealed dorsal and pedal pulses could not be palpated (examined by touch) in the right foot. Additional review revealed Patient #1's foot had a seven by three (7 x 3) centimeter area of ulceration down to the subcutaneous (under the skin) tissues of the foot, ulcerations between the toes had maggots in the wound, and the foot was dusky and cool to the touch. Further review of the PE revealed he/she was hypotensive (low blood pressure) with a systolic B/P (the upper number, the force the heart exerts on the walls of the arteries each time it beats) was in the low 70's (normal systolic range for Patient #1's age was 110-145); hypothermic (low body temperature) with a core temperature of 95 degrees Fahrenheit (F); normal is 98.6 degrees F; and tachycardic (fast heartrate) in the low 100's (normal adult heart rate was 60-100 beats per minute).

Continued review of Patient #1's ED record revealed immediate interventions included initiating a Sepsis Alert that included starting intravenous fluids (IVF) and antibiotics. A warming blanket was applied to warm Patient #1's body. Patient #1's clinical record included a diagnosis of septic shock.

Review of the workup in the medical record included basic labs of complete blood count (CBC) that could help detect a variety of disorders including infections, anemias, immune diseases, and blood cancers, C-reactive protein (CRP) to check for an inflammation response; venous blood gases (VGB) to check for low blood flow in the lower extremities, and blood cultures to check for a blood infection. Additionally, an abdominal computed tomography angiography (CTA) with run-off to the bilateral lower extremities to check for peripheral artery disease was completed.

Review of Physician's Assistant-Certified (PA-C) #1's progress note (dictation date/time of 08/23/2023/11:23 AM), revealed General Surgeon (GS) #1 was available for consultation but declined to see Patient #1 because she did not consult for foot and ankle wounds and recommended transfer to another acute care facility. Continued review of PA-C #1's progress notes revealed an outside facility had accepted Patient #1 for a Podiatry consult.

Further review of Patient #1's ED record documented that Patient #1's clinical picture was consistent with septic shock (the most serious stage of sepsis with some mortality rates as high as fifty percent (50%), wound to the right lower extremity, acute kidney injury, and hyponatremia (low sodium level in the blood). The record also documented that prior to Patient #1's transfer, he/she acutely decompensated (a worsening of a patient's clinical status that posed a substantial increase to an individual's short-term risk of death or serious harm) and needed increasing dosages of Levophed (a blood pressure medication) to keep blood pressure stable.

Further review of PA-C #1's progress note, dated 08/23/2023 at 11:23 AM, revealed General Surgeon (GS) #1 was again notified of Patient #1's decompensation and requested her to consult Patient #1. It was documented GS #1 again stated she did not do amputations and did not come to see Patient #1. Per the note, PA-C #1 documented she contacted Facility #2 but they were on diversion also. She again contacted one (1) of the nearby facilities to explain Patient #1's critical status and requested to see if they could over-ride the diversion. The facility reported they would speak to the Chief Medical Officer but stressed the importance of a surgeon evaluating Patient #1. PA-C #1 documented that she had relayed that a request had been made of GS #1 twice, but she had declined both times because she did not do amputations. The nearby facility again stated they would try to over-ride the diversion as Patient #1 was unstable and had been in the emergency department (ED) for nine (9) hours by that time.

Additional review of PA-C #1's progress note, dated 08/23/2023 at 11:23 AM, revealed Patient #1 continued to need increasing doses of Levophed and had consented for a Central intravenous (IV) catheter (a longer, larger tube that was placed in a large vein in the neck, upper chest, or groin to receive fluids, medications, blood, and nutrition). It was during this time that Facility #2 called back and stated they had a Critical Care bed and had accepted Patient #1 for transfer.

During an interview on 01/17/2024 at 7:37 PM via phone with PA-C #1, she stated she had requested General Surgeon #1 (GS #1) to evaluate Patient #1 twice on 08/23/2023. She stated GS #1 was the on-call Physician for General Surgery for 08/23/2023 and should have come to evaluate Patient #1. She stated the on-call medical provider process was that if a medical provider was on call, they had to respond within a certain time frame; and, that time frame for General Surgery was thirty (30) minutes. PA-C #1 stated the first time she notified GS #1 of the consult for Patient #1, GS #1 was in the building, finishing surgery cases. PA-C #1 stated that GS #1 told her (PA-C #1), that she (GS #1) did not do amputations, and the Orthopaedic on-call person should be consulted because they did amputations. PA-C #1 stated the second time she notified GS #1, GS #1 stated to transfer Patient #1 because she did not do amputations.

During the interview on 01/17/2024 at 7:37 PM via phone with PA-C #1, PA-C #1 stated she had conferred with Emergency Department (ED) Physician #1 during Patient #1's visit on 08/23/2023. She stated that the ED had to follow the treating Physician's orders, so Patient #1 was transferred to Facility #2 later that evening. PA-C #1 stated that while arrangements for Patient #1's transfer were being made, he/she sustained a cardiac medical incident that needed to be treated. PA-C #1 stated the cardiac medical incident was stabilized, and Patient #1 was transferred.

During an interview on 01/18/2023 at 8:47 AM with the Vice-President of Clinical Effectiveness and the Director of the Emergency Department, they both stated that any time a consult was made in the Emergency Department, the Consultant needed to see the patient, especially if it was emergent.

On 01/18/2024 at 10:43 AM, General Surgeon (GS) #1 stated she remembered Patient #1. She stated Physician's Assistant-Certified (PA-C) #1 had called her about an amputation patient. She stated, prior to this patient, the Emergency Department (ED) was aware she did not do amputations. When asked how they were aware she did not do amputations, GS #1 stated she had specifically told PA-C #1 several times, but PA-C #1 continued to consult her for foot and ankle concerns. GS #1 stated she had done a handful but none in the three (3) years she had been at Facility #1. She stated the orthopaedic surgeons had privileges to do them, and she did not think she was best prepared to do it. GS #1 stated she had encouraged PA-C #1 to check if an orthopaedic surgeon was available and that she (PA-C #1) had called her twice. When asked about the responsibility of being on-call, she stated that if they called with a general surgery consult, she could provide advice. She stated, if a patient was going to be admitted, they received a face-to-face consult. She stated sometimes they call General Surgery about things when they just need direction. GS #1 stated routinely she did not have a problem with pointing them in the right direction of which service they might need. She stated if it was a trauma case, the on-call service would have to be at the facility in person within thirty (30) minutes. During the interview, GS #1 stated if she was called with a General Surgery consult, she would come in. She stated if she directed them (ED) to another service, her expectation would be that the other service would be contacted for the consult. Further, while interviewing GS #1, she stated if she did not have privileges to do the surgery, she could give them advice. GS #1 stated she was aware Patient #1 had decompensated and that the outside facility that had agreed to accept Patient #1 had to refuse the transfer because they did not have a Critical Care bed available. She stated that if she did not have privileges to do the surgery, she really could not do anything for the patient. Additionally, GS #1 stated her request to have amputations removed from her Credentialing list was made before 08/23/2023.

In the continued interview on 01/18/2024 at 10:43 AM, General Surgeon (GS) #1 stated she was told the patient needed an amputation, and she did not do that. She stated it was well-known among ED providers that she did not do amputations. GS #1 continued the interview by stating she reviewed her privileges the night of 08/23/2023 but did not remember amputation privileges were still on there because she had never done them.

While interviewing ED Physician #1 on 01/18/2024 at 12:47 PM, he stated Patient #1 had presented to the ED with a diabetic septic wound and was transferred. ED Physician #1 stated he worked the 7:00 PM to 7:00 AM shift and recalled he had received Patient #1 in hand-off from the Medical Director. He stated he thought the ED had contacted the on-call General Surgery surgeon earlier before Patient #1 required pressors (low blood pressure medications), but she declined to see Patient #1. He stated he believed right around the time he arrived at the facility at 7:00 PM was when staff put Patient #1 on the pressors. He stated PA-C #1 called the on-call surgeon back and got the same response, that Patient #1 needed to be transferred. He stated PA-C #1 had made it clear that Patient #1 had decompensated further and needed more urgent treatment. ED Physician #1 stated he did not have any hands on with Patient #1, that PA-C #1 was taking care of Patient #1, and he was supervising and conferring with her the entire time. ED Physician #1 stated that a possible EMTALA violation would be hard to defend in this case because Patient #1 had a diabetic foot wound and was septic from the wound. He stated it would also be hard to argue that the patient's management had included source control. He stated a primary thing needed to stabilize Patient #1 would have been to remove the source of the continuing infection. He stated Patient #1's medical decompensation was a direct result of his/her foot. He stated this situation was emergent, and the General Surgeon should have consulted with Patient #1 because he/she had septic shock from the foot infection.

In an interview with the Medical Director (MD) of the ED on 01/18/2024 at 1:15 PM, he stated that PA-C #1 had been the medical provider for Patient #1, but he was supervising her work. He stated, if he remembered correctly, PA-C #1 spoke with General Surgeon (GS) #1 twice, requesting the consult. He stated when a provider requested on-call service, the expectation was they came to see the patient. He stated ED Staff tried not to call the on-call services for non-emergent concerns, but this was emergent. He stated ED Staff saw a lot of concerns we were not comfortable dealing with, but if an on-call service was requested and they were privileged to address the concern, the expectation was for them to come and lay eyes on the patient. He stated, as Medical Director of the ED, his expectation for this scenario was that the on-call physician should have come and seen the patient. By his interpretation of EMTALA, he stated, if there was a procedure needed and the facility had established capability, GS #1 should have come in. Concerning the case of Patient #1, he stated, GS #1 had stated before that she did not do amputations, but her privilege card indicated at the time she could. He stated the facility was an Emergency Department in a rural setting, and the ED was going to sometimes see things that made us uncomfortable.