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93 CAMPUS AVENUE - PO BOX 291

LEWISTON, ME 04243

COMPLIANCE WITH 489.24

Tag No.: A2400

Based on review of documentation and interviews, the facility failed to ensure an on-call physician would respond and appear in the Emergency Department within a reasonable period of time for one of twenty patient records reviewed (Patient #1).

The hospital's policy, "EMTALA - On Call Policy" last reviewed 10/2020, stated in part; "K. Physician Appearance Requirements
1. If a physician on the on-call list is called by the hospital to provide emergency screening or treatment and either fails or refuses to appear within a reasonable period of time, the hospital and that physician may be in violation of EMTALA as provided for under section 1867(d)(1 )(C) of the Social Security Act.
2. If a physician is listed as on-call and requested to make an in-person appearance to evaluate and treat an individual, that physician must respond in person in a reasonable amount of time.
3. If, as a result of the on-call physician's failure to respond to an on-call request, the hospital must transfer the individual to another facility for care, the hospital must document on the transfer form the name and address of the physician who refused or failed to appear within a reasonable time, normally within 30 minutes of the time requested to come in to see the individual in the DED (Dedicated Emergency Department).

On December 9, 2024 at approximately 4:50 PM the Emergency Department physician documented a call to the On-Call surgeon. The note reported the On-Call surgeon after reviewing the case, "He recommends contacting outside surgical specialists." The patient record does not indicate the On-Call surgeon made an in-person appearance to evaluate the patient prior to referring to an outside provider.

This deficient practice had the likelihood to cause harm in all patients presenting to the ED with serious conditions requiring an evaluation by an On-Call specialist.

Refer to Tag A2404

ON CALL PHYSICIANS

Tag No.: A2404

Based on document reviews and interviews, the hospital failed to follow their policies and procedures to ensure its on-call physicians fulfilled their on-call duties, and to accept a patient for whom the hospital had the capability and capacity to treat who presented to the Emergency Department ("ED") with an emergency medical condition (an illness, injury, symptom or condition so serious one should seek care right away to avoid severe harm or serious impairment) for one (1) of twenty (20) patients reviewed (Patient #1).

Findings:

The "EMTALA - On Call Policy", last approved in 07/2024, states in part, "Purpose: To establish guidelines for the hospital and its personnel to be prospectively aware of which physicians, including specialists and sub-specialists, are available to provide additional medical evaluation and treatment necessary to stabilize individuals with emergency medical conditions in accordance with the resources available to the hospital as required by the Emergency Medical Treatment and Labor Act (EMTALA), 42 U.S.C., Section 1395 and all Federal regulations and interpretive guidelines promulgated thereunder."

In addition, the policy states, in part, "The hospital must maintain a list of physicians on its medical staff who have privileges at the hospital or if it participates in a community call plan a list of physicians who participate in such plan. Physicians on the list must be available after the initial examination to provide treatment necessary to stabilize individuals with emergency medical conditions (EMC) who are receiving services in accordance with the resources available to the hospital. The cooperation of the hospital's medical staff members with this policy is vital to the hospital's success in complying with the on-call provisions of EMTALA. The hospital should make its privileged physicians aware of their legal obligation as reflected in this policy and should take all necessary steps to ensure that physicians perform their obligations as set forth herein."

The "Plan for the Provision of Patient Care, Nurse and Clinical/Ancillary Staffing Plan and Contingency Plan" last revised in 02/2024, states in part, " Operating Room ("OR") Scope of Service: This unit provides inpatient and outpatient surgical services to patients ranging from infants (6 months and older) to geriatrics. All services are included with the exception of OB/GYN, neurosurgery, ophthalmology, and plastic surgery. Hours of Service: Regular scheduled hours of operation from 7 AM to 7 PM, Monday-Friday. Elective cases end at approximately 4 PM. Once rooms are dropped down to 2, elective cases are allowed to start based on staffing and expected finish times. All other hours of operation are covered by On Call Coverage. On Call Coverage is from Monday through Friday 7 PM - 7 AM with one team consisting of one nurse and one certified surgical tech, one Anesthesiologist or CRNA. Weekend on call coverage is from 7 AM Saturday to 7 AM Monday and consists of one nurse and one certified surgical tech, one Anesthesiologist or CRNA... ."

In addition, the policy also describes the Intensive Care Unit ("ICU"), "Scope of Service: The ICU is a Moderate Mixed Acuity unit with capacity for (11) eleven patients; all rooms are private. The ICU specializes in the care of adult and geriatric patients with complex and/or unstable medical and post-surgical needs. Older adolescents may be admitted when conditions are within the scope of care and services provided. The SMRMC ICU partners with Hicuity Health care to provide telemedicine support for the care, treatment and services of patients meeting Intensive Care Level... Operating Hours: 24/7... ."

On Monday, 12/09/2024 at 2:17 PM, per the medical record, Patient #1 arrived at St. Mary's Regional Medical Center ("SMRMC") ED with a chief complaint of swelling in groin from a boil. At 2:23 PM, the triage nurse indicated that he/she had an [Emergency Severity Index] of three (3) and documented the following: Patient comes [in] with cyst on left butt cheek and is now on right cheek and swelling has gone to groin now. At 2:34 PM, he/she was brought to a room in the ED and the past medical history indicated Diabetes mellitus, Hyperlipidemia, Hypertension and has smoked a pack of cigarettes per day for thirty (30) years.

On 12/09/2024 at 2:49 PM, Patient #1 was provided with a medical screening exam by Doctor #2. He documented the following: [Patient #1] has a history of diabetes mellitus who presents with/for painful swelling of the right inferior buttocks. Patient #1 states initially the symptoms began a few days ago with a painful cyst on the left buttocks. An evaluation was completed a few days prior at an outpatient urgent care and was placed on Bactrim for concern for a developing abscess. Patient #1 stated the cyst on the left buttocks had resolved however there was progressively worsening swelling and pain on the right inferior buttocks. Patient #1 describes subjective fever, chills, dyspnea, fatigue, and malaise.

The medical decision making documentation is as follows: Vital signs reviewed. Laboratory and image findings indicated in ED course. The patient's symptoms and clinical findings are most concerning for cellulitis with abscess. Less likely necrotizing fasciitis. Will obtain CT imaging of the pelvis. Patient was treated initially with fentanyl.

Per the medical record, Doctor #2 documented the following on 12/09/2024:
- 4:40 PM Radiology indicates concern for necrotizing fasciitis versus Fournier gangrene. I will page our general surgeon on-call, [Doctor #1];
- 4:50 PM [Doctor #1] indicates his concern for the patient being high-risk for poor outcomes and likely to exhibit hemodynamic instability either during or immediately after procedure. He recommends contacting outside surgical specialists;
- 5:15 PM Central Maine Medical Center ["CMMC"] general surgeon indicates that the patient is currently hemodynamically stable and he indicates 1st line treatment for necrotizing fasciitis is immediate treatment in OR from surgery. He indicates at this time there is no reason that our facility cannot provide treatment given we have a surgeon on-call;
- 5:41 PM, the CT of the pelvis with contrast resulted and described the following: 1. Extensive subcutaneous gas seen within the posterior thigh and gluteal region extending suspicious for a necrotizing infection secondary to gas-forming organism. Fournier's gangrene may coexist and clinical correlation is advised.
2. Left medial gluteal cleft abscess described above. 3. Incompletely visualized heterogeneous enhancing exophytic left lower pole renal mass highly suspicious for renal cell carcinoma which will require further evaluation with dedicated imaging of the renal beds. 4. Extensive atherosclerotic disease of the distal abdominal aorta with thrombotic occlusion of the left common iliac artery. High grade stenosis seen involving the origin of the right common iliac artery;
- 5:45 PM, I provided the CMMC transfer center with [Doctor #1's] direct phone number for their surgeon to directly speak with ours; and
- 6:45 PM, I was informed that the patient was accepted to CMMC general surgery.

On 01/27/2025 at 2:31 PM, Doctor #1 was interviewed and he stated the following:
- The Emergency Room doctor called me to discuss the CT scan findings, which I reviewed;
- I realized that our ICU was closing and I saw his/her past medical history which included diabetes, high blood pressure, etc., which indicated a need for ICU and possibly more surgeries;
- I looked at the reading and based on this and his/her prior medical history, without an ICU, we cannot take this patient;
- He/She will likely have a surge response;
- I did speak with a Central Maine Medical Center surgeon;
- They weren't happy about taking the patient but I explained what was going on and why this patient should go and my concern was that I did not want to transfer an unstable patient;
- The CMMC surgeon asked me if I had seen the patient and I said I had not ... I could tell from the CT and the PMH, what would happen and that we don't have an ICU;
- If I was going to take them to the OR, I would come in; and
- In regard to the patient, I did feel bad and was concerned about dumping ... However, without an ICU, we could not take the patient.

On 01/27/2025 at 8:51 PM, Doctor #2 was interviewed and stated the following:
- He stated, in regard to the patient he saw in the ED - I do remember this patient;
- The patient appeared well, but the area looked bad;
- I explained this patient to Doctor #1 but he was concerned about no ICU and the high risk for this surgery;
- He believed it was too risky for our hospital;
- I spoke to a surgeon at CMMC, and he told me we could handle this patient and declined the transfer;
- I did not want to be in the "middle" so I gave the surgeon [at CMCC] Doctor #1's phone number so that they could talk, surgeon to surgeon; and
- Doctor #1 did not come to see the patient at bedside.

On 1/28/25 at 11:00 AM, Doctor #3, was interviewed and indicated the following:
- Recently, the Chief of Surgery asked to speak with me and I was told that there would be no more call;
- When asked what that meant, he stated there was a hard stop to the OR at 7 PM and no more guidance was given;
- I was told "[OR] does not want to start cases after 5 PM";
- There is no protocol [for the new process], and I have met with leadership multiple times to request this, and they stated they are working on it;
- I performed the required surgery, for Patient #1 about a month ago, to another patient and he/she is doing great, and that patient did not require the ICU following surgery;
- I cannot predict who will need ICU care or not;
- We are still on call to the ED and I will go to bedside 80% of the time;
- For this case, I would typically come in or go to bedside if on site for this case;
- Yes, [since the provision of care has changed] we have received so much pushback when trying to transfer patients;
- This change was made very blindly, as we found out one (1) hour before implementation; and
- From the receiving facility's perspective, I can see how they feel we are "patient dumping".

On 01/28/2025 at 2:00 PM, the Chief Medical Officer ("CMO") was interviewed by phone with the State Agency's Physician Consultant, related to the care for Patient #1, which revealed the following:
- We do not have an ICU or Intermediate Care and that change was effective 12/10/2024 for admitting to ICU;
- The other piece is after hours surgery, but we don't start cases that will end after 7 PM and there are no surgical services from 7 PM Friday to Monday 7 AM;
- On the ICU side, we just don't have it ... if they need critical care, they will have to be transferred;
- Our after-hours process is that if a patients arrive in ED and needs surgical assistance, we would have them talk to the on call surgeon to determine what is needed and discuss if it is something we can manage, can it be done in the time frame that we can accommodate;
- There are no policies and procedures related to this new process;
- The information came to the highest levels a week before about the new changes, with a day surgery platform;
- Before that, I had meetings with medical leadership to share more details and include them in the formatting go forward;
- This description would be written in the Provision of Services;
- I have looked at Patient #1's record;
- My conclusion is that I think it is complicated, presented with possible Fournier's Gangrene, very complicated, the ED Physician had a conversation with the surgeon who determined he/she needed an outside facility;
- The decision making, well, there were a number of points, this happened 12/09/2024, and while the ICU was officially still open, we knew we were not going to have ICU staff after the 10th, for a patient who needed multiple surgical interventions;
- The treatment for his/her diagnosis depends on the location, but typically antibiotics, supportive therapy and surgical debridement;
- This was not done because we didn't feel like we could take care of him/her;
- There are degrees, but yes, Patient #1 had a life-threatening condition;
- Yes, the surgeon, the operating room and the ICU were available at that time;
- The hospital had the capability, but there is a high likelihood that [Patient #1] would need care beyond the surgery that you have to provide; and
- Yes, we were able to perform all of those treatments and I would agree that surgery, antibiotics and stabilizing fluid is the EMTALA obligation.