California – Gastroenterology – Endoscopy In High Risk Patient With Esophageal Scleroderma Results In Complications

A 69-year-old male with diffuse systemic sclerosis, interstitial lung disease, end stage renal disease on hemodialysis, anemia, hypertension, hypoalbuminemia, secondary hypothyroidism, and gastric antral vascular ectasia (“GAVE”) had been referred to a gastroenterology clinic for evaluation of recurrent problems with weight loss and dysphagia.  It was assumed that the patient’s disease had progressed to esophageal scleroderma and that a percutaneous endoscopic gastrostomy (“PEG”) would be necessary to bypass his esophagus and would allow him to take in adequate nutrition without swallowing.  The patient was referred to the gastroenterology clinic for evaluation and a PEG.

On 6/25/2012, the gastroenterologist ordered a PEG, and she scheduled an esophagogastroduodenoscopy (“EGD” or upper endoscopy) and esophageal manometry for the afternoon of 6/25/2012, both elective, non-emergent diagnostic procedures, scheduled to be done on an outpatient basis.  On 6/23/2012 or 6/24/2012, the patient had been discharged from the hospital on antibiotics with home oxygen administration after treatment for aspiration pneumonia.

The gastroenterologist performed a pre-endoscopy history and physical examination in the early afternoon of 6/25/2012 and noted that the patient had active diffuse scleroderma complicated by renal crisis, diffuse systemic sclerosis, interstitial lung disease, GAVE with multiple cauterizations, and end stage kidney disease.  In past medical history, she listed “scleroderma renal crisis, “Started dialysis December 30, 2011,” and “Pneumonia. Admitted to er 6/24/12.”  She noted that the patient had had multiple upper endoscopies for gastrointestinal bleeding prior to this EGD.  Her physical examination listed “Lungs: Clear Auscultation. Clear percussion and Normal Symmetry and Expansion.”  She noted that she, not an anesthesiologist, was ordering sedation.

Sedation was to be administered by a registered nurse.  The gastroenterologist listed Airway as Class 2 and ASA Level (American Society of Anesthesiologists physical status classification system) as 3 (severe systemic disease).

On 6/25/2012 at 2:48 p.m. and ending at approximately 3:15 p.m., the gastroenterologist performed an upper endoscopy on the patient and took biopsies.  Nursing records indicate that sedation consisted of midazolam, 7 mg, administered over the 22 minutes; fentanyl, 175 mcg administered over the 22 minutes, and Cetacaine spray applied to the throat prior to the procedure.

The patient was transferred from the endoscopy procedure room to the recovery area under the care of a registered nurse.  The nurse noted that the patient was unresponsive to verbal and painful stimuli, with blood pressure 108/70, heart rate 86, and O2 saturation 89% on 2 liters delivered by nasal cannula.  A face mask was applied at 10 liters O2 and oxygen saturation went up to 97%.  When the gastroenterologist was notified, she ordered reversal medications: flumazenil 0.25 mg IVP over 15 seconds and Narcan 0.4 mg IVP at 3:40 p.m., and the patient was still unresponsive.  A second dose of flumazenil 0.25 mg IVP was given at 3:43 p.m., and the patient became responsive at 3:44 p.m.  Once the patient was responsive, the gastroenterologist performed the esophageal manometry procedure.  No time is entered in the medical record for this procedure although the gastroenterologist acknowledges that it was done and the results are recorded.

The gastroenterologist was later notified by nursing staff of concerns with the patient’s breath sounds, and the gastroenterologist noted stridor at 4:26 p.m.  She was notified at 5:19 p.m. that the patient’s oxygen saturation was 89% on 5 liters oxygen delivered by nasal cannula.  At 5:20 p.m., the gastroenterologist ordered a chest x-ray due to the inability to wean the patient off oxygen after the endoscopy.  A face mask was applied at 10 liters oxygen at 5:21 p.m., and oxygen saturation went up to 93%.  The chest x-ray indicated “a dense retrocardiac opacity and a left pleural effusion” and a “volume loss in the left lung with mild shift of the mediastinum towards the left.”

After the manometry procedure in the recovery room, the patient’s oxygen saturation was monitored, and when the oxygen saturation remained above 90% for 30 minutes on room air, the patient met endoscopy discharge criteria.  The patient was discharged home with instructions concerning any complications that might arise.

The gastroenterologist states that she arranged to admit the patient to the hospital, but the patient left against medical advice (AMA).  Neither notation of this nor a signed AMA release was found in the record.  Pathology results revealed gastritis and the manometry procedure revealed a condition consistent with esophageal scleroderma.

On 6/27/2012, the patient presented to the emergency department with shortness of breath and cough.  Chest x-ray showed new right lung patchy opacities, and the patient was cachectic.  He was admitted to the intensive care unit for treatment of pneumonia.  The admission diagnosis was “most likely persistent pneumonia, likely aspiration due to esophageal dysmotility.”  The patient failed to improve despite intensive hospital care.  Although the gastroenterologist had scheduled a PEG for 7/2/2012, it was decided that the patient would not go through with the procedure.  Instead, it was decided that the medical team would provide palliative care for the patient.

On 7/4/2012, the patient died with the cause of death listed as aspiration pneumonia due to esophageal dysmotility and end-stage scleroderma with severe malnutrition as a contributing factor.

The Board deemed the gastroenterologist’s conduct as falling below the standard of care for the following reasons:

1) The gastroenterologist failed to provide an accurate analysis of the patient’s suitability for the endoscopic and manometry procedures.

2) She classified the patient as an ASA Level 3, which denotes an individual with stable multiple system disease that limits daily activity without immediate danger of death.

3) At the time of the EGD and manometry done by the gastroenterologist, the patient had just been released from another hospital, where he had been treated for aspiration pneumonia and discharged on antibiotics and home oxygen.

4) By reason of the patient’s recent aspiration pneumonia and the necessity for home oxygen administration, his ongoing scleroderma renal crisis which necessitated hemodialysis, his persistent interstitial lung disease, and his frequent bleeding and cauterizations for GAVE, his condition was not stable, and elective procedures at this time were contraindicated.  The patient’s classification was clearly ASA level 4, which denotes an individual with severe, incapacitating disease, poorly controlled or end-stage, at risk for death due to organ failure.

5) The gastroenterologist failed to provide for an anesthesiology consultation, given the patient’s unstable and life-threatening condition, and instead elected to provide conscious sedation directed by the gastroenterologist and administered by a registered nurse.  The level of sedation administered to the patient during the upper endoscopy procedure was relatively large for an individual with so many co-morbid conditions, and an anesthesiologist or nurse anesthetist should have been in attendance.

6) Since both procedures were elective, the gastroenterologist failed to reschedule the procedures for a time when the patient was stable and able to tolerate conscious sedation directed by the gastroenterologist and administered by a nurse.

7) The patient had a very unstable post-procedure course in the recovery room.  He was unresponsive to verbal and painful stimuli and oxygen saturation was below 90%.  Reversal medications had to be administered before the patient became responsive.  When the patient became responsive, the gastroenterologist performed the esophageal manometry in the recovery room.  This procedure was unnecessary to determine the need for a PEG and further endangered the health of the patient.

8) The respondent approved sending the patient home with instructions after his oxygen saturation was above 93% for 30 minutes.  The patient was a very high-risk patient for elective procedures and had had a very unstable post-procedure course in the recovery room, including the development or exacerbation of pneumonia.  Under these circumstances, in conjunction with his numerous co-morbidities, it was unsafe to send the patient home.  There was no record found of the patient leaving the clinic AMA.

The Board issued a public reprimand against the gastroenterologist.  Stipulations included continuing medical education in the topics of pre-operative patient evaluation, informed consent, sedation, and medical record keeping.

State: California

Date: May 2017

Specialty: Gastroenterology, Hospitalist, Internal Medicine

Symptom: GI Symptoms (GERD, Abdominal Distention, Dysphagia), Cough, Shortness of Breath, Weight Loss

Diagnosis: Gastrointestinal Disease, Pneumonia, Pulmonary Disease

Medical Error: Unnecessary or excessive treatment or surgery, Failure of communication with other providers, Lack of proper documentation

Significant Outcome: Death, Hospital Bounce Back

Case Rating: 5

Link to Original Case File: Download PDF

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