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2301 HIGHWAY 71

SPIRIT LAKE, IA 51360

COMPLIANCE WITH 489.24

Tag No.: A2400

I. Based on document review and staff interviews, the hospital's emergency department (ED) staff failed to follow the hospital's policies when the ED staff failed to provide an adequate medical screening examination for 1 of 62 patients (Patient #11) that presented to the ED and requested care. Failure of the hospital's ED staff to provide an ongoing/adequate medical screening examination within the hospital's capabilities resulted in the hospital's ED staff delaying the transfer of a patient without determining the cause of the patient's pain. The hospital's administrative staff identified an average of 701 patients presented to the ED and requested emergency care per month.

Findings include:

1. Review of the hospital policy "Emergency Medical Screening and Examination and Treatment," reviewed 10/2018, revealed in part, "...Medical Screening Examination: For any individual who comes to the Emergency Department, and on whose behalf a request is made for examination or treatment, an appropriate medical screening examination shall be provided within the capabilities of the Emergency Department (including ancillary services routinely available to the Emergency Department) to determine whether or not an emergency medical condition exists...."

2. Review of Patient #11's medical record revealed Patient #11 arrived at the hospital's emergency department by ambulance on 11/10/18 with the complaint of sudden onset of left hip and lower back discomfort today without injury. The patient received a computed tomography (CT, a detailed x-ray of a patient's internal organs) scan of Patient #11's lumbar spine (LS - lower back) and left hip. CT results revealed no fractures. No other studies were ordered.

Refer to 2406 for additional information.


II. Based on document review and staff interview, the acute care hospital's administrative staff failed to ensure that the on-call orthopedic surgeon presented to the ED to provide stabilizing treatment when requested. The hospital's administrative staff identified 52 patients with orthopedic complaints who presented to the ED seeking care from January 1, 2018 to November 30, 2018, Three patients (Patients #8, 55, and 56) presented with an orthopedic emergency and at the request of the on-call orthopedic surgeon were transferred to another hospital 21 miles away, prior to receiving stabilizing treatment within the hospital's capabilities and capacity, so the surgeon could continue to provide on-call surgical coverage at Hospital B.

Failure of the on-call orthopedic surgeon to come to the ED when requested placed all patients with an unstabilized emergency at risk for a delay in their treatment and further deterioration of their condition up to and including death.

Findings include:

1. Review of the document "Specialty Coverage Agreement Orthopedic Surgery Call," signed by the hospital's Chief Executive Officer on 4/29/2011, revealed in part, "Hospital wishes to ensure specialty emergency coverage in orthopedic surgery for its emergency patients... Contractor shall provide off-site, on-call coverage of the emergency department. Contractor's obligation to provide services hereunder shall include the following: (a) Be immediately available by telephone or pager, and available to respond physically in the emergency department, ... as soon as possible, and no later than sixty (60) minutes after receiving a telephone call or page during all scheduled shifts. (b) Provide all necessary screening exams, stabilization, emergency care, follow-up or treatment and admissions, referrals and transfers as deemed medically appropriate for patients presenting to the Hospital on an unscheduled basis."

2. Review of patient medical records included the following:

Patient # 8 presented to the ED on 11/7/18 at 10:50 AM with complaints of continued pain and swelling in finger of right hand following outpatient treatment. ED physician G diagnosed Patient #8 with an abscess (a pocket of infection) in the finger of their right hand (an Emegency Medical Condition). ED Physician G called on-call Orthopedic Surgeon K, who was on-call for the hospital. On-call Orthopedic Surgeon K indicated they were at Hospital B (21 miles away). ED physician G documented the transfer of Patient #8 for access to the on-call orthopedic surgeon K's service. Patient #8 was transferred to Hospital B via private car at 12:56 PM on 11/7/18, so on-call Orthopedic Surgeon K could continue providing on-call surgical coverage at Hospital B.

Four hours after presenting to the ED for care, Patient #8 arrived at Hospital B for stabilizing treatment of their orthopedic emergency medical condition.


Patient # 55 presented to the ED on 4/26/18 at 1:35 AM with complaints of pain in their left wrist after a fall around 11:00 PM the previous evening. An x-ray revealed splintering of the large forearm bone near the wrist (an Emergency Medical Condition). ED Physician L discussed Patient #55's care with on-call Orthopedic Surgeon K, who was on-call for the hospital. On-call Orthopedic Surgeon K indicated they were close to Hospital B and requested ED Physician L transfer Patient #55 to Hospital B (21 miles away) so that on-call Orthopedic Surgeon K could treat Patient #55. Patient #55 was transferred to Hospital B by private car on 4/26/18 at 3:05 AM for stabilizing treatment, so on-call Orthopedic Surgeon K could continue providing on-call surgical coverage at Hospital B.

Approximately 2 hours after presenting to the ED for care, Patient #55 arrived at Hospital B for treatment of their orthopedic emergency medical condition.


Patient #56 presented to the ED on 4/18/18 at 7:45 PM with complaints of pain in their right lower leg after falling shortly prior to arriving at the ED. ED Physician M ordered x-rays of Patient #56's leg, which revealed fractures in both of the bones in Patient #56's right leg. ED Physician M contacted on-call Orthopedic Surgeon K, who was listed as on-call for the hospital, regarding Patient #56. On-call Orthopedic Surgeon K was at another hospital when ED Physician M contacted him. On-call Orthopedic Surgeon K requested ED Physician M to transfer Patient #56 to Hospital B (21 miles away) for surgery. Patient #56 was transferred to Hospital B by ambulance on 4/18/18 at 9:10 PM so on-call Orthopedic Surgeon K could continue providing on-call surgical coverage at Hospital B.

Approximately 4 hours after presenting to the ED for care, Patient #56 arrived at Hospital B for treatment of their orthopedic emergency medical condition.

Patient #56 had an emergency medical condition of fractures in both of the bones in the lower right leg.


3. During an interview on 12/13/18 at 9:05 AM, the Director of Emergency and Outpatient Services stated he was not aware of any policy that addresses orthopedic call and that if the orthopedic on-call physician was not available to come to the hospital the patient may need to be sent to another hospital 21 miles away for further evaluation by the orthopedic surgeon on-call. The Director of Emergency and Outpatient Services was not sure what the contract stated in regards to the patient may need to be sent to another hospital 21 miles away for further evaluation by the orthopedic surgeon on-call.

Refer to 2404 for additional information.

ON CALL PHYSICIANS

Tag No.: A2404

I. Based on document and patient medical records review, and staff interview, the acute care hospital's administrative staff failed to ensure that the on-call orthopedic surgeon presented to the ED to provide stabilizing treatment when requested. The hospital's administrative staff identified 52 patients with orthopedic complaints who presented to the ED seeking care from January 1, 2018 to November 30, 2018, Three patients (Patients #8, 55, and 56) presented with an orthopedic emergency and at the request of the on-call orthopedic surgeon were transferred to another hospital 21 miles away, prior to receiving stabilizing treatment within the hospital's capabilities and capacity so on-call the on-call orthopedic surgeon could continue providing on-call surgical coverage at Hospital B..

Failure of the on-call orthopedic surgeon to come to the ED when requested placed all patients with an unstabilized emergency at risk for a delay in their treatment and further deterioration of their condition up to and including death.

Findings include:

1. Review of the document "Specialty Coverage Agreement Orthopedic Surgery Call," signed by the hospital's Chief Executive Officer on 4/29/2011, revealed in part, "Hospital wishes to ensure specialty emergency coverage in orthopedic surgery for its emergency patients... Contractor shall provide off-site, on-call coverage of the emergency department. Contractor's obligation to provide services hereunder shall include the following: (a) Be immediately available by telephone or pager, and available to respond physically in the emergency department, ... as soon as possible, and no later than sixty (60) minutes after receiving a telephone call or page during all scheduled shifts. (b) Provide all necessary screening exams, stabilization, emergency care, follow-up or treatment and admissions, referrals and transfers as deemed medically appropriate for patients presenting to the Hospital on an unscheduled basis."

2. Review of patient medical records revealed the following instances where the on-call orthopedic surgeon (who was listed as on-call for the hospital) requested the ED physician transfer a patient to Hospital B (21 miles away), where the on-call orthopedic surgeon for Lakes Regional Healthcare could evaluate the patient and provide care to the patient so the on-call orthopedic surgeon could continue providing on-call surgical coverage at Hospital B:

Patient # 8 presented to the ED on 11/7/18 at 10:50 AM. Patient #8 had returned to the ED with complaints of continued pain and swelling in finger of right hand following outpatient treatment. ED physician G diagnosed Patient #8 with an abscess (a pocket of infection) in the finger of their right hand. ED Physician G called on-call Orthopedic Surgeon K, who was on-call for the hospital. On-call Orthopedic Surgeon K indicated they were at Hospital B (21 miles away). On-call Orthopedic Surgeon K agreed to accept a transfer of Patient #8 to Hospital B. The ED staff transferred Patient #8 to Hospital B via private car at 12:56 PM on 11/7/18 so on-call Orthopedic Surgeon K could continue providing on-call surgical coverage at Hospital B.

Patient # 55 presented to the ED on 4/26/18 at 1:35 AM with complaints of pain in their left wrist after a fall around 11:00 PM the previous evening. ED Physician L discussed Patient #55's care with on-call Orthopedic Surgeon K, who was on-call for the hospital. On-call Orthopedic Surgeon K indicated they were closed to Hospital B and requested ED Physician L transfer Patient #55 to Hospital B (21 miles away) so that on-call Orthopedic Surgeon K could treat Patient #55. ED Physician L transferred Patient #55 to Hospital B by private car on 4/26/18 at 3:05 AM so on-call Orthopedic Surgeon K could continue providing on-call surgical coverage at Hospital B.

Patient #56 presented to the ED on 4/18/18 at 7:45 PM with complaints of pain in their right lower leg after falling shortly prior to arrival in the ED. ED Physician M ordered x-rays of Patient #56's leg, which revealed fractures in both of the bones in Patient #56's right leg. ED Physician M contacted on-call Orthopedic Surgeon K, who was listed as on-call for the hospital, regarding Patient #56. On-call Orthopedic Surgeon K requested ED Physician M to transfer Patient #56 to Hospital B (21 miles away) for surgery. ED Physician M transferred Patient #56 to Hospital B by ambulance on 4/18/18 at 9:10 PM so on-call Orthopedic Surgeon K could continue providing on-call surgical coverage at Hospital B.

3. During an interview on 12/13/18 at 9:05 AM, the Director of Emergency and Outpatient Services stated he was not aware of any policy that addresses orthopedic call and that if the orthopedic on-call physician is not available to come to the hospital the patient may need to be sent to another hospital 21 miles away for further evaluation by the orthopedic surgeon on-call. The Director of Emergency and Outpatient Services was not sure what the contract stated in regards to the patient may need to be sent to another hospital 21 miles away for further evaluation by the orthopedic surgeon on-call.

The Director of Emergency and Outpatient Services stated orthopedic specialists provided on-call coverage to the hospital 7 days a week, but the orthopedic surgeons' group was located in another town, 21 miles away from the hospital. Approximately 10 times per month, the on-call orthopedic surgeon would request the Lakes Regional Healthcare's ED physician to transfer a patient to Hospital B (21 miles away) because the orthopedic surgeon was seeing patients in the other town or was in surgery at Hospital B. If the patient presented in the evening, and the on-call orthopedic surgeon wasn't in surgery at another hospital, the on-call orthopedic surgeon would drive to Lake's Regional and evaluate the patient in Lakes Regional Healthcare's ED.

The Director of Emergency and Outpatient Services stated the ED staff always contacted the on-call orthopedic surgeon listed on the on-call schedule. The on-call orthopedic surgeon, who was located in a town 21 miles away from Spirit Lake, would sometimes direct the Lakes Regional Healthcare ED staff to contact an orthopedic surgeon who was not listed as on-call for the hospital, if the on-call orthopedic surgeon knew one of his partners was available in Spirit Lake seeing patients at their clinic, and ask the orthopedic surgeon not listed as on-call to see the patient.

After 5:00 PM and when the orthopedic clinic in Spirit Lake was closed, the ED staff would call the on-call orthopedic surgeon to evaluate the patient in Lakes Regional Healthcare's ED. The orthopedic surgeon would either drive to Lakes Regional Healthcare and evaluate the patient or instruct the ED staff to transfer the patient to Hospital B (21 miles away) to undergo surgery.

The Director of Emergency and Outpatient Services stated if an ED patient suffered a hip fracture or other injury requiring orthopedic surgery at night, the on-call orthopedic surgeon would request a family practice doctor admit the patient to the hospital overnight, and evaluate the patient in the morning for surgery. However, if the patient suffered an injury which the orthopedic surgeon could treat with outpatient surgery, the on-call orthopedic surgeon would direct the ED staff to transfer the patient to Hospital B (21 miles away) for outpatient surgery.


II. The regulatory language, due to a system error, failed to include the availability of on-call physician requirements specified that a hospital must have written policies and procedures in place if a hospital elects to participate in a formal community call plan.

The formal community call plan must include the following elements:

(A) A clear delineation of on-call coverage responsibilities; that is, when each hospital participating in the plan is responsible for on-call coverage.

(B) A description of the specific geographic area to which the plan applies.

(C) A signature by an appropriate representative of each hospital participating in the plan.

(D) Assurances that any local and regional EMS system protocol formally includes information on community-call arrangements.

(E) A statement specifying that even if an individual arrives at a hospital that is not designated as the on-call hospital, that hospital still has an obligation under §489.24 to provide a medical screening examination and stabilizing treatment within its capability, and that hospitals participating in the community call plan must abide by the regulations under §489.24 governing appropriate transfers.

(F) An annual assessment of the community call plan by the participating hospitals.

This STANDARD is not met as evidenced by:

Based on document review and staff interview, the acute care hospital's administrative staff failed to ensure the hospital had written policies and procedures in place to address on-call physicians serving simultaneous on-call duties at several hospitals and ensure the on-call physicians could report to the hospital to provide care to patients. Failure to ensure the hospital had written policies and procedures in place to provide that emergency services are available to meet the needs of patients with emergency medical conditions when it elected to permit on-call physicians to have simultaneous on-call duties could potentially result in the delay of treatment of an emergency room patient that could result in patient harm or death. The hospital's administrative staff identified an average of 701 patients per month which presented to the Emergency Department (ED) and requested emergency care.

Findings include:

1. During an interview on 12/13/18 at 9:05 AM, the Director of Emergency and Outpatient Services acknowledged the hospital was attempting to participate in a formal community call plan for orthopedic physicians on-call but did not have any policies that addressed the hospital's participation in a formal community call plan as required in the regulations. The Director of Emergency and Outpatient Services acknowledged all hospitals in the region shared the same orthopedic surgeon on call and the orthopedic surgeon was on call for multiple hospitals at the same time. If a patient needed specialized care the patient was transferred to the specialist. The Director of Emergency and Outpatient Services acknowledged the hospital lacked clear delineation of on-call coverage responsibilities when each hospital is participating in the plan and was responsible for on-call coverage. The Director of Emergency Services also acknowledged there was lack of documentation of a description of the specific geographic area to which the community call plan applied and lack of a signature by an appropriate representative of each hospital participating in the plan. The Director of Emergency Services verified the lack of documentation of assurances that any local and regional EMS system protocol formally includes information on community-call arrangements. The Director of Emergency Services also verified the lack of a statement that specified that even if an individual arrives at a hospital that is not designated as the on-call hospital, that hospital still has an obligation to provide a medical screening examination and stabilizing treatment within its capability, and that hospitals participating in the community call plan must abide by the regulations that governed appropriate transfers.

MEDICAL SCREENING EXAM

Tag No.: A2406

Based on document review and staff interviews, the hospital's emergency department (ED) staff failed to provide an ongoing/adequate medical screening examination for 1 of 62 patients (Patient #11) that presented to the ED and requested care from 4/14/18 through 12/10/18. Failure of the hospital's ED staff to provide an ongoing/adequate medical screening examination within the hospital's capabilities resulted in the hospital's ED staff delaying the transfer of a patient without determining the cause of the patient's pain. Failure to provide an adequate medical screening examination resulted in the patient's loss of circulation to the patient's legs and resulted in patient death. The hospital's administrative staff identified an average of 701 patients presented to the ED and requested emergency care per month.

Findings include:

1. Review of Patient #11's closed medical record revealed Patient #11 arrived by ambulance at the hospital's ED on 11/10/18 at 3:15 PM with the complaint of sudden onset left hip and lower back discomfort today, symptoms indicative of possible blood clots, particularly in a patient with a history of a repaired abdominal aortic aneurysm (the aorta is the largest artery that delivers oxygenated blood to the body). Documentation revealed Patient #11 complained of pain rated an 8 out of 10 with 10 being the most severe pain. ED physician R ordered a computed tomography (CT) scan of Patient #11's lumbar spine (LS - lower back) and left hip. (CT scan is a special type of x-ray).

At 3:39 Patient #11 was transported to radiology for the CT imaging and returned at 3:59 PM. At 4:11 PM Patient #11 moaned and complained of severe discomfort to her lower back and left hip and numbness in both legs - ED Registered Nurse (RN) S documented the patient's pulse on top of both feet was present. At 4:49 PM ED physician R was at Patient #11's bedside to discuss the CT results and care plan but did not examine the patient's lower extremities. At 5:15 PM ED patient # 11's daughter contacted the nursing staff and provided vascular surgeon H's (vascular surgeon at Hospital C) phone number. Vascular surgeon H had previously operated on patient # 11 to repair an abdominal aortic aneurysm (an emergency medical condition). At 6:21 PM ED physician R spoke on the phone to vascular surgeon H. At 6:30 PM ED RN checked Patient #11's femoral pulses (in the groin area) using a doppler (instrument used to estimate blood flow through a blood vessel). The ED RN documented the patient's femoral pulses were weak and irregular (indicating a lack of arterial blood flow to the patient's lower extremities, an emergency medical condition requiring immediate treatment).

At 6:40 PM family requested that the ED transfer patient # 11 to receive care from vascular surgeon H. At 6:52 PM ED physician R placed an order to transfer Patient #11. At 6:53 PM ED physician R called ER physician T at Hospital C for acceptance of the transfer of Patient #11. At 7:05 PM call placed to Hospital C for consideration to transport Patient #11 by rotary wing helicopter. At 7:29 PM ED RN S was unable to feel or hear by doppler Patient #11's pedal pulses, and documented the patient's lower legs were pale and cool to touch. At 7:33 PM ED physician R called Surgeon H to provide update on patient. At 8:45 PM the air ambulance crew arrived to transport Patient #11 to Hospital C. At 8:54 PM Patient #11 departed the hospital for transport to Hospital C.

Review of Hospital C's medical record revealed Patient #11 was emergently taken to the operating room to remove blood clots in an attempt to treat the loss of circulation in the patient's legs. While in the recovery room, the patient's condition declined and ultimately Patient #11 died as a result of muscle necrosis (death of muscle) due to the blood clots in her legs.

2. During an interview on 12/12/18 at 4:45 PM, ED RN S stated Patient #11 was extremely restless when presented to the ED and the ED staff focused on relieving the patient's pain. ED RN S stated the patient went directly to radiology for a CT scan upon arrival.

During an interview on 12/12/18 at 3:45 PM, ED RN C stated she assisted ED RN S in the care of Patient#11 on 11/10/18. ER RN C stated at the beginning the patient's legs were cool and white/pale but she could feel faint pulses on the top of the patient's feet. ED RN C stated from the 1/2 hour she was in the ED assisting in the care of Patient #11, the patient had declined and no longer was able to feel pulses in the patient's feet.

During an interview on 12/19/18 at 9:05 AM, ED physician R stated that Surgeon H at Hospital C instructed him to check the patient's femoral pulses. ED physician R reported that the patient's femoral pulse was weaker on the left than on the right. ED physician R stated when he told the patient's family that the CT scan results were negative for an abscess, the family requested he transfer the patient to Hospital C. ED physician R stated he called the ED physician at Hospital C who accepted the transfer.

During an interview on 12/17/18 at 4:20 PM, vascular surgeon H stated that at around 7:30 PM he asked ED physician R about patient # 11's femoral pulses and ED physician R had not evaluated them. ED physician R went to the patient's bedside and checked the patient and called Surgeon H back and said he thought he felt them. Surgeon H stated he then asked ED physician R to get a Doppler and check the pulses and call him back. The ED physician R called Surgeon H back and said both legs were numb and the patient complained of back pain. Surgeon H stated he met Patient #11 in Hospital C's ER about 10 PM and there was obviously no pulses in either of her legs - there was rigor in both legs from the lack of blood flow. Surgeon H stated immediately arranged for patient # 11 to go to the operating room and was in surgery from 11 PM until 2 AM. Ultimately Patient #11 died as a result of muscle necrosis (death of muscle) due to blood clots in her legs.

The evidence in the medical record revealed that ED Physician R failed to perform an appropriate and sufficient examination (neurovascular examination) of the patient's lower extremities which would have allowed for a more prompt transfer for surgery by the vascular surgeon.