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1955 WEST FRYE ROAD

CHANDLER, AZ 85224

COMPLIANCE WITH 489.24

Tag No.: A2400

Based on reviews of clinical records, review of hospital policies and procedures, and staff interviews, it was determined the hospital failed to enforce policies and procedures that comply with the requirements of 42CFR 489.20 and 42 CFR 489.24, responsibilities of Medicare participating hospitals in emergency cases as evidenced by:

A2406: Medical Screening Examination: The hospital failed to ensure Patient #1's Medical Screening Examination (MSE) included continued monitoring and documentation of the patient's needs based on the patient's presenting symptoms. The patient presented with signs and symptoms of compartment syndrome documented by the ED and Trauma providers. The ED physician documented two hours prior to transfer that the patient needed to be evaluated for compartment syndrome. There was no documentation of continued monitoring by ED / Trauma staff for compartment syndrome during that two hour period the patient was still in the ED. The patient was immediately assessed to have compartment syndrome upon arrival to Hospital #2 and was taken emergently to the operating room for a fasciotomy. Circulation in the extremity was not sustained, and an above the knee amputation was performed within 24 hours.

A2407: Stabilizing Treatment: The hospital failed to provide stabilizing treatment that was within their capability prior to transferring Patient #1 to another acute care hospital (Hospital #2).

A2409: Appropriate Transfer: The hospital failed to ensure there was a written consent or certification signed by a physician for Patient #1 indicating the reason(s) the transfer was being requested as well documentation that the patient and/or the patient's representative of the risks and benefits of the transfer.

MEDICAL SCREENING EXAM

Tag No.: A2406

Based on review of clinical records, policies and procedures, and staff interviews, it was determined the hospital failed to ensure Patient #1's Medical Screening Examination (MSE) included continued monitoring and documentation of the patient's needs based on the patient's presenting symptoms. The patient was identified to have signs and symptoms of compartment syndrome in his left lower leg. There was no assessment of the patient's left lower leg by ED and/or Trauma staff documented between 3:10 p.m. and when the patient left the ED at 5:19 p.m. The patient was immediately assessed to have compartment syndrome upon arrival to Hospital #2 and was taken to the operating room for emergency surgery.

Findings include:

The hospital's policy and procedure on the subject of "Dignity Health Emergency Medical Care / Emergency Medical Treatment and Labor Act (EMTALA) Corporate Policy" included: "Definitions...H. 'Emergency Medical Condition' means a medical condition manifesting itself by acute symptoms of sufficient severity...such that the absence of immediate medical attention could reasonably be expected to result in: 1. Placing the health of the individual...in serious jeopardy; a. Serious impairment to bodily functions; or b. Serious dysfunction of any bodily organ or part...."I. 'Medical Screening Examination'...Medical Screening Examinations depend on the individual's presenting symptoms, and an ongoing process that may include vital signs, history and physical examination of affected or potentially affected symptoms, consideration of known chronic conditions, or testing needed to determine the presence of an Emergency Medical Condition, documented in the record and reflect continued monitoring according to the individual's needs until it is determined that the individual does not have an Emergency Medical Condition.

Patient #1 was taken by emergency medical services to Chandler Regional Medical Center on 06/21/2021 at 2:37 p.m. The patient was evaluated by Provider #1 whose documentation at 2:37 p.m. included: "The patient...presents to the ED via EMS with trauma related injuries which occurred earlier today. Per EMS patient's (family member) called 911 when she couldn't get the patient up off the garage floor...(Family member) did not see him fall but found him on the ground afterwards. Patient has burns to both his knees as well as swelling and pain to his left foot. He states the car was in park and denies any crush injuries...I spoke with trauma surgery and they were concerned about the burns over the joints of the knees as well as the left. There is a dopplered pulse of the left foot although weak to palpation. I spoke with the burn center at (Hospital #2) (name of physician) who accepted the patient ER to ER for evaluation. He will be flown via helicopter to the burn center...His left foot has clinically improved. The color has also improved. Doppler pulses still present...The helicopter said they will be here in 20 minutes...Clinically has improved...1510 (3:10 p.m.) The helicopter is here to pick him up to take him to the burn center. He is now able to move is left foot which is new. He has decreased sensation still however the color has significantly improved. He does have some tenderness in the calf. Will need to be evaluated for compartment syndrome. They can do that at the burn center. He is clinically improved...." Documentation in the Emergency Department Transfer of Care Summary revealed the patient left the ED at 5:19 p.m., over two hours later. There was no documentation that the patient's left lower leg was re-assessed during that two hour period of time. Staff #2 reported the monitoring and care of Patient #1 was with the trauma nurse until transfer and a "full" assessment would only happen if the patient became unstable or a significant change was noticed.

Documentation dated 6/21/2021 by the trauma surgeon, Provider #2, in the History and Physical included: "Exam: Bilateral upper & lower extremities: atraumatic - appro (sic) 3% BSA (body surface area) full thickness burns over bilateral knees, superficial partial thickness burns over the entire L (left) foot up to mid calf (4.5%) and ankle join on the R (right) foot (3%); L calf compartments firm, R LE (lower extremity) compartments soft...Medical Decision Making & Plan: Approx 15% BSA burn over the surface of multiple joints; rhabdomyolysis, lactic/metabolic acidosis, AKI (acute kidney injury), poss NSTMI (Non-ST elevation myocardial infarction). I believe that this represents an acute illness that poses a threat to life accompanied by major comorbidities, including obesity, parkinson dz (disease)...Pt is critically ill - however, given his concurrent injuries coupled with significant burns over multiple joints I discussed transfer to (Hospital #2) burn center with Dr. (Provider #1) of the ED.

A review of the clinical records from Hospital #2 revealed the patient arrived there on or around 6:01 p.m. and was evaluated in the hospital's Burn Unit ED at 6:22 p.m. An ED physician's note dated 6/21/2021 at 6:45 p.m. included: "Briefly, this is a... male who was accepted to the burn center after a trauma evaluation at an outside hospital. When he was receiving his evaluation here at the burn center emergency department, they found the left leg to be quite tense, with concern for compartment syndrome, and he was then transported back here to the emergency department for trauma evaluation and resuscitation." Another ED physician note at 6:58 p.m. included: "Patient presents to the ED after being transferred to the burn center from an outside hospital earlier today. The burn attending reports that they received notification for transfer due to concern for burn over joint. However, upon the patient's arrival to the ED patient had significant concern for compartment syndrome, rhabdomyolysis with hyperkalemia, as well as elevated troponin with EKG abnormality. Patient was activated as a category 2 trauma in conjunction with trauma surgery consulted due to patient's complex medical presentation....Abrasions and partial thickness burns to left lower extremity less than 1% total body surface area. Patient with tense compartment of the left lower extremity. Pulses not able to be dopplerable...Fascia iliac block performed under ultrasound guidance. Patient taken emergently to the OR for fasciotomy...."

Documentation in the Trauma Exam H & P (History and Physical) included: "Burn wound noted over anterior aspects of both knees, L leg compartments are firm, foot appears mottled, pulses not palpable or dopplerable. Reduced sensation...Outside hospital workup revealed hyperkalemia, rhabdomyolysis, diffuse ST segment elevations and elevated troponins concerning for acute STEMI. Upon arrival here, left leg was edematous, compartments were hard, pulses were not present and the foot appeared mottled."

The procedure was performed on 6/21/2021 at 7:32 p.m. The operative note included: "This is a... male who was transferred from Chandler Hospital Patient was getting out of his car from the garage and had a ground-level fall. He was found on the ground several hours later by his wife. Patient was worked up as a trauma at the outside hospital and transferred to the burn ED for concern of contact burn on his bilateral lower extremities. His initial work-up at the outside hospital included a CT head, CT C-spine, x-ray of the left knee and left ankle. Upon being evaluated in the burn ED we noticed that his left lower leg compartments were tight in comparison to the right lower leg. There was a faint palpable DP pulse. Patient denied any sensation to the lower leg from the knee down. There was delay cap refill of the left lower extremity over 3 seconds. Patient was unable to move his left toes. He denied any pain on passive flexion of the foot. There was no imaging from outside hospital of the left tib-fib. Patient was then brought to the trauma ED and leveled as a trauma level 2. His EKG show ST elevation concerning for acute MI and STEMI. Cardiology was consulted. Took the patient emergently to the OR for left lower leg 2 incisions, 4 compartment fasciotomies. This was an emergent procedure with (sic) did not obtain consent prior to the procedure."

On 6/22/2021 the patient's left lower leg became cold with decreased sensation and progressive mottling. Vascular surgery was consulted for a possible revascularization procedure. A General Surgery progress note included: "(Patient #1) who presents with MI, LLE compartment syndrome, rhabdo now with pulseless, mottled foot and concern for fixed acidosis with ischemic limb, contributing to severe acidosis with impending cardiac collapse...No indication for revascularization procedure, patient would almost certainly lose patency again and repair would not last. Agree that amputation will represent potentially life-saving procedure at this time, defer to trauma team re: mechanism and procedure. The patient's overall condition deteriorated and he died on 06/29/2021.

An interview with Provider #1 was conducted on 11/4/2021. He said he called a trauma alert after his initial assessment of the patient because of the nature and severity of the injuries. He explained the burns and the assessments of the patient's left lower leg up to the time the patient was transferred as documented in the clinical record. Provider #1 maintained the patient was stable at the time of transfer.

A separate interview was conducted with Provider #2 on 11/4/2021. Provider #2 recalled that Patient #1 was very sick at the time of his assessment. Provider #2 also stated the patient was stable at the time of transfer.

The audio recording of the telephone call from the ED physician at Chandler Regional (Provider #1) to the burn unit physician at Hospital #2 on 6/21/2021 was reviewed. Provider #1's report of the status of Patient #1 included the history of what brought the patient to the ED, pertinent labwork performed and values; vital signs and cognitive status. The report of the patient's left lower leg was: "...he has pretty significant burns to his knees bilaterally and his left foot is completely erythematous, looks burned. We don't have a great pulse in that foot although we can get it with Doppler." Provider #1 did not communicate the concern of a potential compartment syndrome of the left lower leg that he documented in the ED record.

In summary, the patient arrived in Chandler Regional Medical Center' Emergency Department on 6/2/2021 at 2:37 p.m. Physician documentation identified concern with the patient's left lower extremity at the time of arrival. The ED physician documented at 3:10 p.m. that Hospital #2 needed to evaluate the patient for compartment syndrome. This was not communicated to Hospital #2 during the physician to physician call requesting Hospital #2 to accept the patient in transfer. There was no documentation that ED and/or Trauma staff assessed the left lower extremity prior to the patient's transfer at 5:19 p.m. The patient arrived at Hospital #2 at 6:01 p.m. Documentation in Hospital's #2 clinical records included: "Upon arrival here, left leg was edematous, compartments were hard, pulses were not present and the foot appeared mottled."

STABILIZING TREATMENT

Tag No.: A2407

Based on reviews of clinical records, policies and procedures, and staff interview, it was determined the hospital failed to provide stabilizing treatment that was within their capability prior to transferring Patient #1 to another acute care hospital (Hospital #2). The ED physician documented at 3:10 p.m. that the patient was clinically improved but needed to be evaluated for compartment syndrome at the receiving hospital. There was no documentation that the patient's left leg was assessed by ED and/or Trauma staff between 3:10 p.m. and when the patient left the hospital at 5:19 p.m. The patient was found to have compartment syndrome of his left lower leg at the time of arrival to Hospital #2 and taken emergently to the operating room for a fasciotomy. The patient's left lower leg was not able to sustain recirculation, and an above-the-knee amputation was performed within 24 hours.

Findings include:

The hospital's policy and procedure on the subject of "Dignity Health Emergency Medical Care / Emergency Medical Treatment and Labor Act (EMTALA) Corporate Policy," (Policy Number 9.100) included: "Definitions...N. 'To Stabilize' means, with respect to an emergency medical condition, to either provide such medical treatment of the condition as may be necessary to assure, within reasonable medical probability that no material deterioration of the condition is likely to result from or occur during the transfer of the individual from the hospital...2. Exam (Medical Screening Examination) to be provided within the capabilities of the Hospital. The examination must include all services within the capabilities of the hospital, which, in the judgment of the emergency Physician or other treating physician are necessary to screen and/or stabilize an individual with an Emergency Medical Condition...."

The hospital's policy and procedure on the subject of "Plan for the Provision of Care and Service" included: "Chandler Regional Medical Center is a 338-bed Level 1 Trauma facility providing acute medical and surgical services on an inpatient and outpatient basis to residents of Chandler, Arizona as well as the surrounding communities...Major patient care services provided at Chandler Regional Medical Center include Medical/Surgical...Critical Care, Intermediate Care...twenty-four (24) hour Emergency Services...."

Refer to Tag A2406 for details related to Patient #1.

Chandler Regional Medical Center identified the patient needed to be assessed for compartment syndrome in his left lower leg, however, did not ensure there was continuous monitoring of the extremity and stabilizing treatment as indicated.

APPROPRIATE TRANSFER

Tag No.: A2409

Based on reviews of clinical records, policies and procedures, and staff interviews, it was determined the hospital failed to ensure for Patient #1, that there was a written consent or certification signed by a physician indicating the reason(s) the transfer was being requested as well documentation that the patient and/or the patient's representative of the risks and benefits of the transfer.

Findings include:

Documentation in the hospital's policy and procedure on the subject of "Dignity Health Emergency Medical Care / Emergency Medical Treatment and Labor Act (EMTALA) Corporate Policy (Policy Number: 9.100) included: "1. If the individual has an Emergency Medical Condition, the individual is to be treated in the DED (Dedicated Emergency Department) until the condition is stabilized or the individual can be appropriately transferred...The hospital will not transfer an individual with an unstabilized emergency medical condition unless the individual requests the transfer or a physician certifies that the medical benefits reasonably expected from the provision of treatment at the receiving facility outweigh the risks to the individual from the transfer. The hospital must provide additional examination and treatment as may be required to stabilize the emergency medical condition until the individual leaves the hospital."

Patient #1's clinical record did not include a copy of the above physician's certification for transfer.

Staff #4 acknowledged during an interview on 11/4/2021 that the clinical record did not contain a copy of the "transfer form."