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35 MEDICAL CENTER PARKWAY

AUGUSTA, ME 04330

EMERGENCY SERVICES

Tag No.: A1100

Based on record review from Maine General Medical Center (MGMC) and the Trauma Center, interviews with key staff at both hospitals, and a review of nationally accepted professional standards, it was determined that the hospital failed to recognize the life-threatening severity of the patient ' s presenting condition, failed to provide appropriate stabilizing measures prior to transfer, and failed to have adequate systems in place to identify and respond to critical, time-sensitive patient care issues. These findings present an Immediate Jeopardy to the health and safety of patients served by the Emergency Department at MGMC.

Findings include:

1. On July 5, 2010 a 34 year old patient was brought by ambulance to the Emergency Department at MGMC - Augusta, arriving at 14:20 according to the registration form. The patient had been riding an ATV when he/she struck a tree.

2. The American College of Surgeons ' " ATLS " , Advanced Trauma Life Support Course, (7th revision) entries on page 71 reads: " Profound circulatory shock, evidenced by hemodynamic collapse with inadequate perfusion of the skin, kidneys, and central nervous system, is easy to recognize. However, after the airway and adequate ventilation have been ensured, careful evaluation of the patient's circulatory status is important to identify early manifestations of shock that include tachycardia and cutaneous vasoconstriction. Sole reliance on systolic blood pressure as an indicator of shock results in delayed recognition of the shock state. " ... " The normal heart rate varies with age. Tachycardia is present when the heart rate is greater than ... 100 in an adult. "

3. The ambulance run sheet documented that his/her vital signs in the ambulance at 13:53 were a blood pressure, (BP) 150/100, a pulse, (P) of 100 and a respiratory rate, RR of 20. Seventeen minutes later at 14:10 his/her BP was lower at 130/94, and an increased pulse of 120, the ambulance transported him/her to the MGMC ' s ED in Augusta.

4. The MGMC Nursing Assessment at 14:30 recorded a third set of vital signs which demonstrated the profound changes of BP 70/41, P 155 and RR 37. At 14:40 the BP was 77/48, P155, and RR 38.

5. The American College of Surgeons ' " ATLS " , Advanced Trauma Life Support Course, (7th revision) entries on page 71 reads: " ...after the airway and adequate ventilation have been ensured, careful evaluation of the patient's circulatory status is important to identify early manifestations of shock that include tachycardia and cutaneous vasoconstriction. Sole reliance on systolic blood pressure as an indicator of shock results in delayed recognition of the shock state. Compensatory mechanisms may preclude a measurable fall in systolic pressure until up to 30% of the patient's blood volume is lost. Specific attention should be directed to pulse rate, respiratory rate, skin circulation, and pulse pressure (the difference between systolic and diastolic pressure). Tachycardia and cutaneous vasoconstriction are the usual and early physiologic responses to volume loss in most adults. " ... " Tachycardia is present when the heart rate is greater than ... 100 in an adult. "

6. According to the patient ' s medical record, the patient received 1,000 milliliters of Sodium Chloride 0.9% Solution intraveneously starting at 14:37. The record continued that at 14:50 two units of uncrossmatched O negative blood started infusing. The MGMC Nursing Assessment noted that at the time the patient left the ED, at 15:00, the BP was 95/53, P was 141 and RR 35.

7. In spite of the documentation that the patient continued with tachycardia and an increased respiratory rate even after intraveneous infusions of fluids and blood, the ' Consultation Report ' dictated by the MGMC On-Call Surgeon on July 7, 2010 noted " the patient ' s hemodynamics continued to improve. " Additionally, the vital signs documented in the patient ' s record demonstrated that his/her blood pressure had not returned to his/her pre-arrival blood pressure.

8. The Emergency Physician evaluated him/her on arrival and in his/her note documented, " Equal breath sounds, with tachypnea and normal heart sounds with tachycardia. Left upper quadrant abdominal tenderness and abdominal guarding " . Two IV ' s [intraveneous lines] were placed and uncrossmatched O negative blood transfusions were ordered.

9. In the Emergency Physician ' s note, the Clinical Impression was " Multi Trauma, Question Ruptured Spleen " . In spite of the clinical impression of " Multi Trauma, " during an interview on November 12, 2010, Trauma Surgeon A at the Trauma Center, stated, " To save this patient ' s life there had to be surgery done immediately. The bleeding had to be stopped immediately. The patient should have had chest tubes inserted, intubated, chest x-rays done, and taken to the OR [Operating Room] prior to transfer. "

10. The American College of Surgeons ' " ATLS " , Advanced Trauma Life Support Course, (7th revision) entries on page 71 reads: " ...after the airway and adequate ventilation have been ensured, careful evaluation of the patient's circulatory status is important to identify early manifestations of shock that include tachycardia and cutaneous vasoconstriction. Sole reliance on systolic blood pressure as an indicator of shock results in delayed recognition of the shock state. Compensatory mechanisms may preclude a measurable fall in systolic pressure until up to 30% of the patient's blood volume is lost. ... Accordingly, any injured patient who is cool and tachycardic is in shock until proven otherwise. "

11. The MGMC Emergency Physician called the Trauma Center and asked Trauma Surgeon A to accept the patient. The time of this call was recorded as 14:25. [Note: This time was recorded by the Trauma Center, not MGMC.] An audio file was supplied by the Trauma Center, and a transcript of this telephone conversation with the Trauma Surgeon A follows:

MGMC Emergency Physician: " We ' ve got a young [patient] involved in a dirt bike accident, said [he/she] hit a tree at 35 miles per hour had no loss of consciousness, was brought here by ambulance with pain in [his/her] left ribs and left hip, ah, [he/she] had vitals, stable vital signs in the field but when [he/she] got here [his/her] blood pressure was 70/40, and [his/her] pulse of 160, ah, [he/she] is quite tender in [his/her] left upper quadrant, so I ' m suspecting a splenic rupture, [he/she] has good breath sounds on the left side. "
Trauma Surgeon A: " Yeah, is [his/her] pressure still low ... " " ... my concern is that with a pressure that low, [he/she] might not do well on the way here, you guys have a general surgeon on call today? " ... " generally if you ' re unstable and its a spleen, the general surgeon should do that because by the time they get here, you know, it can be time, it can be serious time lost ... I guess if there is none available there ... "
MGMC Emergency Physician " let me see if I can get someone here quickly. "
Trauma Surgeon A: " We ' re here, we certainly are, it ' s just that with a pressure that low it ' s a pretty good bleed! "

12. Despite Trauma Surgeon A ' s comments on what had to be done to save the patient ' s life, the ATLS guidelines on shock, and Trauma Surgeon A ' s recommendations to MGMC ' s Emergency Physician, during an interview on November 10, 2010, the MGMC On-Call Surgeon stated " the patient was not in shock. [His/Her] pulse was 110 and [he/she] had pedal pulses. " Additionally, he stated that he was unaware of the vital signs taken by the nurses.

13. According to the record, the MGMC On-Call Surgeon was called at 14:30 and arrived in the ED at 14:40. There was no contemporaneous note from the On-Call Surgeon. During an interview on November 15, 2010, the MGMC On-Call Surgeon stated that he was " unaware that this was a formal consult. This patient was brought to Maine General mistakenly. " There was a ' Consultation Report ' dictated on July 7th, two (2) days after the patient was at MGMC. During the same interview, the On-Call Surgeon stated that he wrote this after the Chief Medical Officer told him that this case was being discussed. He also stated that is why he " wrote the report as a narrative, rather than as a physical exam. "

14. The American College of Surgeons ' " ATLS " , Advanced Trauma Life Support Course, (7th revision) stated on page 71: " Most injured patients who are in hypovolemic shock require early surgical intervention to reverse the shock state. Therefore, the presence of shock in an injured patient demands the involvement of a surgeon. "

15. The MGMC On-Call Surgeon called Trauma Surgeon A before arriving in the Emergency Department to see the patient. During an interview on November 10, 2010, the MGMC On-Call Surgeon confirmed that his initial conversation with Trauma Surgeon A occurred before he had seen or assessed the patient.

16. During an interview on November 12, Trauma Surgeon A said after speaking with the MGMC On-Call Surgeon, he immediately called the MGMC Emergency Physician. The time of the decision to transfer was recorded as 14:45. [Note: This time was recorded by the Trauma Center, not MGMC.] A transcript of this conversation from the Trauma Center audio file follows:

Trauma Surgeon A: " I spoke with a [MGMC On-Call Surgeon], no help, not much help, he ' s unwilling to come help you anyway... " MGMC Emergency Physician: " Yeah, he ' s here but he said no help ... "

17. The American College of Surgeons ' " ATLS " , Advanced Trauma Life Support Course, (7th revision) stated on page 77: " The diagnosis and treatment of shock must occur almost simultaneously .... The basic management principle to follow is to stop the bleeding and to replace the volume loss. " The American College of Surgeons continue on page 141, " Injury(ies) to the liver, spleen, or kidneys that results in shock, hemodynamic instability, or evidence of continuing bleeding remain indications for urgent celiotomy. " [Note: Celiotomy is defined as " surgical incision into the abdominal cavity " according to ' Taber ' s Cyclopedic Medical Dictionary, Edition 20 ' edited by Donald Venes, MD, page 366.]

18. The dictation done by the MGMC On-Call Surgeon on July 7, 2010, two (2) days after the patient ' s death, failed to recognize the patient ' s " profound circulatory shock, " failed to recognize the implications of the tenderness in the left upper quadrant correlated with the Emergency Physician ' s diagnosis of " question ruptured spleen, " and failed to consider the benefits of providing immediate surgical intervention to stabilize the patient ' s hemorrhage, which had been recommended by Trauma Center ' s Trauma Surgeon. This ' Consultation Report ' instead stated: " At approximately mid-afternoon on July 5, 2010, Monday, I was called urgently by [MGMC Emergency Physician] to help assess a patient who had just arrived in the emergency room with a very low blood pressure and significant tachycardia .... I contacted [Trauma Surgeon A], the on-call surgeon in Lewiston for their trauma receiving center... Focused physical examination revealed positive dorsalis pedis and posterior tibial pulses bilaterally in the feet and positive radial artery pulses in the arms bilaterally. The patient had a significant amount of tenderness in the left upper quadrant but no evidence of flail chest or fractured sternum. The patient was respiring at about 22 to 24 breaths per minute in a non-labored fashion and was oxygenating with saturations in the mid-90 ' s on minimal supplemental oxygen .... With continued administration of intravenous fluid, the patient's hemodynamics continued to improve. After a few minutes in consultation with [MGMC Emergency Physician], we decided to continue with the planned transport of the patient to Lewiston as [Trauma Surgeon A] had agreed to be the accepting surgeon in my conversation with him previously. We arranged for 4 units of uncrossmatched blood to accompany the patient, and transfusion of 2 units was initiated as [he/she] was being loaded onto the ambulance, 1 unit into each large bore peripheral line. After the patient was enroute, with an emergency nurse in attendance with [him/her] in the ambulance, I contacted [Trauma Surgeon A] by phone again. I briefed him on my focused physical examination and assessment of the patient and with the interventions that had been undertaken here in Augusta, namely fluid and blood transfusion. Hemoglobin drawn in the ER was about 13. [Trauma Surgeon A] agreed in proceeding with the transfer and agreed to be the accepting physician. "

19. There was also no evidence in his dictated ' Consultation Report ' that the MGMC On-Call Surgeon discussed his examination or clinical impressions with Trauma Surgeon A before the patient was en-route to the receiving hospital.

20. In spite of documented hypotension and tachycardia, the MGMC On-Call Surgeon, in an interview on November 10, 2010, stated that he was unaware of the vital signs taken by the nurses.

21. The Maine General Medical Center Transfer form lists the risks and benefits of the transfer. It contains a check mark under " Service, equipment or staffing is not available at MGMC - Trauma Surgeon " . It also included " Benefits of Transfer, Trauma Care " and " Risks of Transfer, Deterioration of Condition En Route. "

22. In spite of the documentation on the ' Transfer Form ' that no trauma surgeon was available at MGMC and the benefit of transfer would be " trauma care, " examination of MGMC ' s On-Call Surgeon ' s privileges revealed that he possessed trauma privileges to provide trauma care. A review of MGMC Trauma Surgeon ' s medical staff privilege request form dated 4/26/2009 demonstrated that he requested and was granted privileges for " the comprehensive management of trauma, musculoskeletal, hand and head injuries, and complete care of critically ill patients with underlying surgical conditions in the emergency department and intensive care units " . He was also granted privileges to perform abdominal surgery, including splenectomy and other surgery of the spleen and other lymphatic structures. He also requested and was granted privileges to perform " Administration of Sedation or Anesthesia " .

23. In an interview with the MGMC On-Call Surgeon on November 10, 2010, he confirmed that he did not consider surgery at MGMC. He said that with a diagnosis of multi-trauma the patient should not be operated on at MGMC, and that the OR response time was not the issue. He confirmed that he had privileges for the care of trauma victims, and had privileges to perform a celiotomy and splenectomy if necessary. The MGMC On-Call Surgeon also stated when he worked in a trauma center, he slept with his beeper, and that time was of the essence. However, in a non- trauma center time is not of the essence.

24. In an interview with the MGMC Chief Medical Officer on November 10, 2010, he stated that he believed that MGMC has the capacity and capability to care for this patient. He continued that MGMC ' s medical staff will care for trauma victims " if there is a blizzard, but that it is faster to go to [the Trauma Center] than to mobilize the OR here " .

25. According to the MGMC ' s OR manager, OR policy states that the OR staff must be " dressed and ready to go " when on call for emergency surgery " within 30 minutes " .

26. The patient ' s records from MGMC and the Trauma Center showed that the patient left MGMC at approximately 15:00 and arrived at 15:37, which is approximately 37 (thirty-seven) minutes. [Note that arrival in the Emergency Department is not equivalent to arrival in the Operating Room prepared for surgery.]

27. During an interview on November 12, 2010 with the Chief of Trauma at the Trauma Center, he stated that ATLS principles for this patient are that as the patient presented in " profound shock " , an emergency celiotomy to find and stabilize the bleeding was mandatory. He also stated that the patient could not have had a free " aortic rupture " since those are immediately fatal. He also stated that if this patient had an aortic tear that had not ruptured, the ATLS principles would mandate an exploration of the abdomen (celiotomy), to stabilize the immediately life-threatening hemmorhage.

28. During an interview on November 12, 2010, the Chief of Trauma at the Trauma Center also stated that he had arranged a meeting with the MGMC Chief of Surgery and Chief of Emergency Medicine to discuss this patient ' s care at MGMC. He stated that he believed that the patient should have been operated on at MGMC. He reported that the MGMC Department Chiefs had told him that MGMC could not operate on patients in less than one hour and that there was no reason they needed to be faster. He also stated that all the participants of this meeting characterized the conclusion as " agreeing to disagree " .

29. During an interview on November 9, 2010, the MGMC Chiefs of Surgery and Emergency Medicine confirmed that at the meeting with the Trauma Center, that they explained that MGMC could not operate on patients in less than one hour and that there was no reason they needed to be faster. They also stated that all the participants of this meeting characterized the conclusion as " agreeing to disagree " .

30. The MGMC Chief Medical Officer stated, during an interview on November 9, 2010, that he thought the care of this patient in the Emergency Department was " appropriate " and " there was nothing that they did that required review. "

31. Despite no autopsy, the Trauma Center " OP Note ' Final Report ' " documented, " The mediastinum still seemed pushed on the left side probably from hemoperitoneum which was only partially evacuated and continuous bleeding in the right chest. Again, I was convinced by the physical examination with distention of the abdomen and the hemotoma in the left flank, that some massive hemoperitoneum was present as well. "

32. During an interview on November 12, 2010, the Chief of Trauma at the Trauma Center was joined by Trauma Surgeon B, the surgeon who cared for the patient at the Trauma Center. Trauma Surgeon B said that he opened the patient ' s chest and cross-clamped the aorta in order to control the patient ' s hemmorhage, and there was no evidence of aortic tear or rupture. He stated that the patient died from exsanguination [massive bleeding].

33. Despite that there was no post-mortem examination, the ' Certificate of Death ' listed the " diseases, injuries, or complications which caused death " as " hemorrhagic shock; " " bilateral hemothorax, massive hemoperitoneum; " " blunt trauma torso; " and " motorcycle accident. "