HospitalInspections.org

Based on staff interviews, clinical record review and document review the hospital failed under the provider agreement to:

1) stabilize and provide treatment to Patient 100, who had sepsis, a perforated bowel and required emergency surgery. (A2407)

2) transfer Patient 100 who was not stabilized with the necessary care and services of a critical care transport to the same level of care. (A2409)

The cumulative effects of these system problems resulted in the hospital's inability to ensure the health and safety of Patient 100 when the hospital did not stabilize, provide treatment and further transferred Patient 100 to the same level of care. These failures contributed to Patient 100's death.

Based on interview and record review, for 1 of 26 sampled patients (Patient 100), the hospital failed to:

1. Notify and request an on-call surgeon's evaluation of an imaging study (CT scan) which revealed a gastrointestinal perforation (hole through the intestinal wall) with air and feces within the abdomen.

2. Provide stabilizing treatment for Patient 100, who had an emergency medical condition (severe sepsis with abdominal perforation).

3. Transferred Patient 100, who was in a critical condition and was unstable, without a critical care transport/nurse ambulance (CCT/RN) to another hospital, which provided the same level of service.

Patient 100 died 7 hours after transfer with discharge diagnosis that included: perforated transverse colon, fecal peritonitis, and severe sepsis with profound multi-organ failure.

Gastrointestinal perforation causes considerable mortality and usually requires emergency surgery. Rapid diagnosis and treatment of these conditions is essential to reduce the high mortality of late-stage presentation.

Findings:

The Sonoma Valley Fire and Rescue Authority Ambulance trip report, Incident # 14-0002114, indicated that on 7/6/14 at 6:25 a.m. Patient 100 was sent to Hospital 1 via "Response code to scene - emergent with lights and sirens" for an initial assessment of a reported fever of 105 degrees Fahrenheit (F), with no palpable pulses or blood pressure, a respiratory rate of 32 and pain reported as 8 of 10 (pain scale 0 = no pain to 10 = excruciating pain) from a long term care facility.

During an interview, on 9/23/14 at 9:15 a.m., Surgeon A, from Hospital 2, stated that ER Physician B called on two separate occasions about Patient 100 on 7/6/14. The first call was around 10 a.m. and the ER physician stated that Patient 100 was receiving treatment for sepsis and the probable source of the infection was pneumonia, Surgeon A requested to be updated when the CT scan of the abdomen was done, as Patient 100 had surgery for diversional ileostomy (surgical formation of an opening of the intestine to the surface of the abdomen, through which fecal matter is emptied) on 6/26/14. The ER physician called back around 2 p.m. and stated that Patient 100's CT scan showed air and feces within the abdominal cavity and the plan was to transfer Patient 100 back to Surgeon A at Hospital 2, for continuity of care. Surgeon A stated that he requested that the surgeon on call at Hospital 1 evaluate Patient 100 and ER Physician B stated that the surgeon's at Hospital 1 would not evaluate this patient and wanted Patient 100 sent back to the operating surgeon. Surgeon A stated the he accepted the transfer of Patient 100 as emergency surgery was the only option for treatment. When queried, Surgeon A stated that ER Physician B did not tell him that Patient 100 was on a dopamine drip (a vasopressor used to increase blood pressure) and that he never would have agreed to the transfer if this was known, and that ER Physician B had stated that Patient 100 was stable. Surgeon A stated that Patient 100 arrived in extremis (near death) with no palpable blood pressure or pulses, with Kussamal respirations (deep and labored breathing pattern often associated with severe metabolic acidosis, particularly diabetic ketoacidosis but also renal failure) and required immediate intubation (placement of a tube into the windpipe for a ventilator) in the ER, and was then rushed to surgery. Patient 100 died shortly after surgery in the intensive care unit.

The ED [Emergency Department] Simple History and Physical, dated 7/6/14 at
1:25 p.m., Section: ED Course & Medical Decision Making noted: Patient [Patient 100] had extensive abdominal surgery the previous month at another facility... Cultures [blood and urine] were obtained, 2 IV antibiotics were started and aggressive fluid hydration initiated [2,000 milliliters (ml) within the first hour]...The case was discussed with [Surgeon A from Hospital 2] at 10:05 a.m....concurred with medical treatment of this patient, but wanted to be informed following the abdominal CT result [series of x-ray images of abdomen]. The patient had a subsequent decrease in blood pressure and was started on a dopamine drip, with good results...An attempt was made to taper off the dopamine and further treatment the patient with additional intravenous hydration [2,000 ml]. The CT findings were discussed at 1:15 p.m., with [Surgeon B at Hospital 2], who accepted the patient in transfer to [name of Hospital 2]. The patient is be transported by critical care transport.


The ED [Emergency Department] Simple History and Physical, dated 7/6/14 at 1:25 p.m., Vital Signs noted: Most recent set of vitals: Vital signs noted at 7 a.m. revealed blood pressure (BP) of 86/71, and respirations of 38 at 7:02 a.m., while on 10 liters (L) of oxygen by non-rebreather (NRB) mask [delivers a higher concentration of oxygen].

The ED [Emergency Department] Simple History and Physical, dated 7/6/14 at 1:25 p.m., Laboratory section included: "ABG [Arterial blood gases 7/6/14 at 9:25 a.m.] on 100% oxygen by non-rebreather mask showed a pH 7.28 (range 7.35-7.45 ph), PCO2 49 range (33-45mm Hg), PO2 63 (range 75-85mm Hg), bicarbonate 18 (range 22-26 meq/L) and oxygen saturation 89% (range 95-100%), [Patient 100's compromised breathing, metabolic acidosis, which indicates signs of sepsis] ...Procalcitonin [PCT] significantly elevated, greater then 200 H (range 0.00-0.05 ng/mL) [marker for bacterial infections, PCT greater then or equal to 10 ng/mL]... Elevated lactate at 4.6 (range 0.7-2.1 mmol/L)..." [Lactate, in patients with suspected sepsis or septic shock, is a marker for cellular hypoxia (decreased oxygen). A level above 4.0 mmol/L is associated with a 27% mortality rate].

The ED [Emergency Department] Simple History and Physical, dated 7/6/14 at 1:25 p.m., Medical Imaging Section noted:..the radiologist noted that the patient has a bowel perforation at an unknown site, with extensive fecal material and air in the abdominal cavity.

ER Physician B physician orders, dated 7/6/14 at 10:56 a.m.: RN to administer and document bolus infusion of 1000 ml NS[normal saline], followed by 2nd bag of 1000 ml NS to make total of 2000 ml. and at 11:25 a.m., dopamine to start at 10 micrograms per kilogram per minute (mcg/kg/minute) STAT [immediately] (Dopamine range 2 - 20 mcg/kg/min).

The Intake and Output record dated 7/6/14 6:45 a.m. through 7/7/2014 at 1:08 a.m., had no entry for intake, but did note 200 ml of urine output - noted at 1:53 p.m.

Patient 100's Vital sign record and medication records dated 7/6/14 indicated:
12:00 p.m. Blood pressure (BP) 77/38 (normal adult range 120/80), P 108 (normal adult range 60 - 100), Respiration (R) 24 (normal adult range 12-16), Oxygen saturation (oxygen level in the blood - O2 sats) 92% (normal adult range 95-100%) with 10 L Oxygen via Non rebreather (NRB) mask
(normal adult range reference - John Hopkins Medicine Health Library)

12:30 p.m. BP 77/38, Pulse 108, R 24, O2 sats 90% with 10 L via NRB mask

12:39 p.m. BP 63/49, Pulse 118, R 29, O2 sats 89% decreased with 10L via NRB mask

12:44 p.m. Dopamine started at 10 mcg/kg/min (ranges 5 - 20 mcg/kg/min)

1:03 p.m. Dopamine increased to 15 mcg/kg/min

1:19 p.m. B/P 144/75, Pulse 129, R 26, O2 sats 91% with 10L via NRB mask, Temperature 98.6 degrees Fahrenheit, tympanic (ear);

1:21 p.m. Dopamine decreased to 12 mcg/kg/min;

1:28 p.m. B/P 149/46, Pulse 129, R 29, O2 sats 94% with 10L via NRB;

1:29 p.m. Dopamine increased to 18 mcg/kg/min,

1:42 p.m. B/P 123/27, Pulse 122, R 29, O2 sats 94%, oxygen was increased to 15 L via NRB and continued Dopamine at 18 mcg/kg/min.


The Sonoma Valley Fire and Rescue Authority Ambulance trip report- Incident # 14-0002119 indicated:

2:05 p.m. Patient 100 was transported by ambulance with a paramedic and RN E in attendance - via "Response code to scene - emergent with lights and sirens."

2:09 p.m. Decreased BP 80/53, Pulse 127, R 30, O2 sats 83 %.

2:14 p.m. BP 94/63 Pulse 114, R 30, O2 sats 79 %.

2:28 p.m. Arrived at Hospital 2 - travel time of 23 minutes.

The Authorization for Transfer record, dated 7/6/14 and signed by ED physician B noted:

Section 1 - The patients emergency medical condition was stabilized such that within reasonable medical probability, no material deterioration in the condition or expected chances for recovery of the patient is likely to result from or occur during transfer.

Section 3 - the receiving facility has agreed to transfer, time noted is 1:18 p.m.

Section 5: to be completed by transferring physician: Reasons for transfer, including summary of risks and benefits: "Continuity of care - request of patient's surgeon."

Updated status as of 1:40 p.m., "critical but stable for transport."

Clinical progress notes, dated 7/6/14 at 1:45 p.m. from RN E noted: Pt [Patient 100] is pale, some use of accessory muscle [Inadequate oxygen can cause a person to work harder to breathe, requiring the use of accessory muscles. Using these muscles indicates a potential injury or disease process that is affecting a person's ability to breathe.], BS [breath sounds] rhonchi [rattling lung sounds], abd [abdomen] distended and firm, fingers cold and cyanotic [blue discoloration of the skin indicating low level of oxygen], radial [wrist] pulse barely palpable.


During an interview on 9/23/14 at 9:15 a.m., when asked if the information in the notes of 1:45 p.m., about Patient 100's condition, was reported to the physician, RN E stated that this was not a change, and it was not reported as Patient 100 had been in that condition for quite a while. When queried about the oxygen saturation levels prior to and during transfer, RN E stated that the device to measure the oxygen level was attached to a finger and the levels were not reliable because Patient 100's hands were so cold, cyanotic and without adequate pulses. RN E stated that at the time of transfer "...she [Patient 100] was stable for one or two hours, we weren't doing a lot, were not adding medications, oxygen levels were marginal at 85 to 92. She [Patient 100] was not doing well, [ER Physician B] was aware of the oxygen sats and vital signs and I had told him about the blue lips and ashen color. My feeling, [Patient 100] should have been intubated (insert a tube through the mouth into the windpipe for a ventilator- breathing machine) before leaving."



During an interview, on 9/18/14 at 3 p.m., ER Physician B stated that after the CT results indicated that Patient 100 needed surgery he did not recall which of the on call surgeons was called. But the surgeon requested that if possible, to transfer the patient to the operating surgeon, which is within the standard of care. "I don't think that I documented it." Patient 100's condition was the same the entire time I took care of [Patient 100]. Additionally, ER Physician B stated that it was not unusual to transfer patients who are on dopamine drips, and that surgeons were reluctant to take over care from the operating surgeon on a case. The standard of care for abdominal perforations is to stabilize medically first and then transfer. The condition of the patient, when placed in the ambulance was the same throughout the time I cared for [Patient 100].


During interviews, on 9/20/14 at 11:05 a.m., and 9/23/14 at 9:24 a.m., Surgeon C, the on call surgeon for 7/6/14 for Hospital 1, stated that the ER physician did not call about Patient 100, but "if I had been called I would have come in immediately to evaluate the patient, I cannot state if I would have done surgery, I would need to have evaluated the situation...I was just sitting at home all afternoon. I did receive a call to come in around 5 p.m., but not for Patient 100." Surgeon C also stated that print outs his telephone call log validated that no calls were received prior to 5 p.m. Surgeon C did look at Patient 100's medical record at Hospital 2 and felt that Patient 100 was clearly not stable for transfer and it was "definitely not in the patients best interest to transfer" as Patient 100 was far too critical upon arrival at Hospital 2.


During an interview, on 9/20/14 at 10 a.m., Surgeon D, the surgeon that ED Physician B stated might have been called, stated: "I was not involved with this case at all, I was out of town that holiday weekend. I was on call the next day [Monday 7/7/14]."


During an interview on 9/23/14 at 11 a.m., and continued at 1:05 p.m., the paramedic (Paramedic G) on the ambulance that transferred Patient 100 to Hospital 2 stated: If the hospital cannot wait to arrange a CCT/RN, they have an agreement with the hospital to transport with an RN, who is responsible for the IV drips, which is outside the paramedic scope of practice. Patient 100 had a very distended abdomen and was working very hard to breathe and he was not sure the oxygen saturation readings from the finger were accurate. The ambulance does include basic and advanced life support equipment, the paramedic can intubate, but only after the patient is unconscious as the paramedic can not give IV sedation (which can be done by CCT/RN). Additionally, Paramedic G stated that it was not clear why P100 was sent Code 3 to Hospital 1, was there for over 6 hours and then sent Code 3 to Hospital 2 who provided the same services, and that this was very unusual.

Hospital 2's Emergency Department Record, dated 7/6/14, Report #: 0709-0173, by ER Physician F indicated: "...Extremely critical presentation...Apparently septic, with septic shock maintained on dopamine near maximum dosing. Borderline oxygenation prior to transfer, but apparently worsening en route...On arrival here the patient has a blood pressure and oxygen saturations difficult to measure (presumably very low) and demonstrating Kussamal breathing; presumably blowing off her metabolic acidosis. Has some acrocyanosis [blue extremities] and appears in a very critical condition, if not extremis...arrives in a very critical condition, needing her airway secured and mechanical ventilation to help her compensate for a presumed severe metabolic acidosis... extremely poor long-term or short-term prognosis..."

Surgeon A's discharge summary report indicated: Diagnosis: 1. Perforated transverse colon, 2. Fecal Peritonitis, and 3. Severe sepsis with profound multi-organ failure. Patient 100 expired at 9:30 p.m.


During interviews on 9/17/14 at 10:40 a.m., 9/18/14 at 2:30 p.m., and 9/19/14 at 4 p.m., the Emergency Room Director stated that after review of the case, that Patient 100 should have remained and had emergency surgery. Patient 100 was sent to Hospital 2 via basic life support transport ambulance with a Registered Nurse (RN E) and not a Critical Care Transport/RN ambulance (CCT/RN), as this type of ambulance took 2- 4 hours to arrange, and the community standard was to send an ER nurse. The ER nurses were responsible for the IV medications that were running, as this was outside the paramedic's scope of practice.


During interview's on 9/17/14 and 9/18/14 the Chief Medical Officer (CMO) for the hospital stated that the transfer of Patient 100 on 7/6/14 from the hospital emergency room to another hospital for treatment of an abdominal perforation with sepsis had been evaluated. The CMO stated that Patient 100 was definitely not stable for transfer. The receiving hospital (Hospital 2), provided the same level of services. Hospital 1 had a general surgeon on call and an operating room and staff available on 7/6/14, the day that Patient 100 was transferred to Hospital 2. Additionally, the CMO stated that Patient 100's surgeon (Surgeon A) was not on staff at Hospital 1 and the physicians at Hospital 1 had some reluctance to care for another surgeon's cases. The CMO concurred that this was a probable EMTALA violation and that the standard of care for patients with abdominal perforations called for emergency/immediate surgery, and he did not agree with the decision of Emergency Room Physician (ER Physician B) to transfer this patient.

"Intra-abdominal infections, range from uncomplicated appendicitis to fecal peritonitis...The treatment of patients with complicated intra-abdominal infections involve both surgical and antibiotic therapy...Studies have demonstrated that there is an increased risk of death as patients transition from sepsis to severe sepsis and septic shock. In the context of intra-abdominal infections, severe sepsis represents the diagnostic threshold separating stable and critical clinical conditions. Thus, early detection of severe sepsis and prompt, aggressive treatment of the underlying organ dysfunction is an essential component of improving patient outcome...Patients with severe sepsis and septic shock may present with inadequate perfusion. Poor tissue perfusion can lead to global tissue hypoxia (loss of oxygen to body tissues), and in turn, to elevated levels of serum lactate...Dopamine administration was successful in only 31% of patients...Diffuse abdominal rigidity suggests peritonitis and should be addressed promptly by means of aggressive resuscitation and surgical intervention..." Infection Diseases Society Of America, World Society of Emergency Surgery - Guidelines for management of intra-abdominal infections. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3545734/

Based on interview and record review, for 1 of 26 sampled patients (Patient 100), the hospital transferred Patient 100, who was in a critical condition and was unstable, without a critical care transport/nurse ambulance (CCT/RN) to another hospital, which provided the same level of service.

Findings:

During interviews on 9/17/14 at 10:40 a.m., 9/18/14 at 2:30 p.m., and 9/19/14 at 4 p.m., the Emergency Room Director stated that after review of the case, that Patient 100 should have remained and had emergency surgery. Patient 100 was sent to Hospital 2 via basic life support transport ambulance with a Registered Nurse (RN E) and not a Critical Care Transport/RN ambulance (CCT/RN), as this type of ambulance took 2- 4 hours to arrange, and the community standard was to send an ER nurse. The ER nurses were responsible for the IV medications that were running, as this was outside the paramedic's scope of practice.

The ED [Emergency Department] Simple History and Physical SVH, dated 7/6/14 at 13:25 Statement of Medical Necessity Section noted: "The patient [Patient 100] is acutely septic and has an intra-abdominal perforation."

During an interview, on 9/23/14 at 9:15 a.m., Surgeon A, from Hospital 2, stated that ER Physician B called on two separate occasions about P100 on 7/6/14. The first call was around 10 a.m. and the ER physician stated that Patient 100 was receiving treatment for sepsis and the probable source of the infection was pneumonia, Surgeon A requested to be updated when the CT scan of the abdomen was done, as Patient 100 had surgery for diversional ileostomy (surgical formation of an opening of the intestine to the surface of the abdomen, through which fecal matter is emptied) on 6/26/14. The ER physician called back around 2 p.m. and stated that Patient 100's CT scan showed air and feces within the abdominal cavity and the plan was to transfer P100 back to Surgeon A at Hospital 2, for continuity of care. Surgeon A stated that he requested that the surgeon on call at Hospital 1 evaluate Patient 100 and ER Physician B stated that the surgeon's at Hospital 1 would not evaluate this patient and wanted Patient 100 sent back to the operating surgeon. Surgeon A stated the he accepted the transfer of Patient 100 as emergency surgery was the only option for treatment. When queried, Surgeon A stated that ER Physician B did not tell him that Patient 100 was on a dopamine drip (a vasopressor used to increase blood pressure) and that he never would have agreed to the transfer if this was known, and that ER Physician B had stated that Patient 100 was stable. Surgeon A stated that Patient 100 arrived in extremis (near death) with no palpable blood pressure or pulses, with Kussamal respirations (deep and labored breathing pattern often associated with severe metabolic acidosis, particularly diabetic ketoacidosis but also renal failure) and required immediate intubation in the ER, and was then rushed to surgery. Patient 100 died shortly after surgery in the intensive care unit.


The Authorization for Transfer record, dated 7/6/14 and signed by ED physician B noted:
Section 1 - The patient ' s emergency medical condition was stabilized such that within reasonable medical probability, no material deterioration in the condition or expected chances for recovery of the patient is likely to result from or occur during transfer.
Section 3 - the receiving facility has agreed to transfer, time noted is 1:18 p.m.
Section 5: to be completed by transferring physician: Reasons for transfer, including summary of risks and benefits: "Continuity of care - request of patient's surgeon."
Updated status as of 1:40 p.m., "critical but stable for transport."

Clinical progress notes, dated 7/6/14 at 1:45 p.m. from RN E noted: Pt [Patient 100] is pale, some use of accessory muscle [Inadequate oxygen can cause a person to work harder to breathe, requiring the use of accessory muscles. Using these muscles indicates a potential injury or disease process that is affecting a person's ability to breathe], BS [breath sounds] rhonchi [rattling lung sounds], abd [abdomen] distended and firm, fingers cold and cyanotic [blue discoloration of the skin indicating low level of oxygen], radial [wrist] pulse barely palpable.


During an interview on 9/23/14 at 9:15 a.m., when asked if the information in notation at 1:45 p.m., about Patient 100's condition was reported to the physician, RN E stated that this was not a change, and it was not reported as Patient 100 had been in that condition for quite a while. When queried about the oxygen saturation levels prior to and during transfer, RN E stated that the device to measure the oxygen level was attached to a finger and the levels were not reliable because Patient 100's hands were so cold, cyanotic and without adequate pulses. RN E stated that at the time of transfer "...she [Patient 100] was stable for one or two hours, we weren't doing a lot, were not adding medications, oxygen levels were marginal at 85 to 92. She [Patient 100] was not doing well, [ER physician B] was aware of the oxygen sats and vital signs and I had told him about the blue lips and ashen color. My feeling, [Patient 100] should have been intubated (insert a tube through the mouth into the airway) before leaving."


During an interview, on 9/18/14 at 3 p.m., ER Physician B stated that after the CT results indicated that Patient 100 needed surgery he did not recall which on call surgeons was called. But the surgeon requested that if possible, to transfer the patient to the operating surgeon, which is within the standard of care. "I don't think that I documented it." Patient 100's condition was the same the entire time I took care of [Patient 100]. Additionally, ER Physician B stated that it was not unusual to transfer patients who are on dopamine drips, and that surgeons were reluctant to take over care from the operating surgeon on a case. The standard of care for abdominal perforations is to stabilize medically first and then transfer. The condition of the patient, when placed in the ambulance was the same throughout the time I cared for [Patient 100].

During an interview on 9/23/14 at 11 a.m., and continued at 1:05 p.m., the paramedic (Paramedic G) on the ambulance that transferred Patient 100 to Hospital 2 stated: If the hospital cannot wait to arrange a CCT/RN, they have an agreement with the hospital to transport with an RN, who is responsible for the IV drips, which is outside the paramedic scope of practice. Patient 100 had a very distended abdomen and was working very hard to breathe and he was not sure the oxygen saturation readings from the finger were accurate. The ambulance does include basic and advanced life support equipment, the paramedic can intubate, but only after the patient is unconscious as the paramedic cannot give IV sedation (which can be done by CCT/RN). Additionally, Paramedic G stated that it was not clear why P100 was sent Code 3 to Hospital 1, was there for over 6 hours and then sent Code 3 to Hospital 2 who provided the same services, and that this was very unusual.

Hospital 2's Emergency Department Record, dated 7/6/14, Report #: 0709-0173, by ER Physician F indicated: "...Extremely critical presentation...Apparently septic, with septic shock maintained on dopamine near maximum dosing. Borderline oxygenation prior to transfer, but apparently worsening en route...On arrival here the patient has a blood pressure and oxygen saturations difficult to measure (presumably very low) and demonstrating Kussamal breathing; presumably blowing off her metabolic acidosis. Has some acrocyanosis [blue extremities] and appears in a very critical condition, if not extremis...arrives in a very critical condition, needing her airway secured and mechanical ventilation to help her compensate for a presumed severe metabolic acidosis... extremely poor long-term or short-term prognosis..."

Surgeon A's discharge summary report indicated: Diagnosis: 1. Perforated transverse colon, 2. Fecal Peritonitis, and 3. Severe sepsis with profound multi-organ failure. Patient 100 expired at 9:30 p.m.

During interviews on 9/17/14 and 9/18/14 the Chief Medical Officer (CMO) for the hospital stated that the transfer of Patient 100 on 7/6/14 from the hospital emergency room to another hospital for treatment of an abdominal perforation with sepsis had been evaluated. The CMO stated that Patient 100 was definitely not stable for transfer. The receiving hospital (Hospital 2), provided the same level of services. Hospital 1 had a general surgeon on call and an operating room and staff available on 7/6/14, the day that Patient 100 was transferred to Hospital 2. Additionally, the CMO stated that Patient 100's surgeon (Surgeon A) was not on staff at Hospital 1 and the physicians at Hospital 1 had some reluctance to care for another surgeon's cases. The CMO concurred that this was a probable EMTALA violation and that the standard of care for patients with abdominal perforations called for emergency/immediate surgery, and he did not agree with the decision of Emergency Room Physician (ER Physician B) to transfer this patient.