THIS IS A CONFIDENTIAL PEER REVIEW DOCUMENT€¦ · surgery. However, if the hysterectomy was unnecessary, the patient clearly would not have suffered the aortic injury. Assuming

Peer Review Report

THIS IS A CONFIDENTIAL PEER REVIEW DOCUMENT Client: General Regional Medical Center Project #: GRMC EC120811 OB-GYN MR#: 123456 Review Performed By: J. Jones, MD Date of Report: November 27, 2011 This document was prepared at the request of General Regional Medical Center in order to provide an independent, professional opinion of the care rendered to the above referenced patient. MDReview was asked by the client to review the care rendered comprehensively and specifically as it relates to concerns posed by the client in the cover letter. This review is based solely on the information provided by the client. Physician Reviewer Background: [MDReview will provide the physician reviewer’s CV] Case Overview: A 76-year-old gravida 7, para 7, patient on unopposed estrogen presented with postmenopausal bleeding. She had an attempted robotic hysterectomy, which was interrupted secondary to hypotension and bradycardia after four trocars were placed. Blood transfusions and Neo-Synephrine were started. The patient was transferred to the PACU, and she was seen by a consultant who ruled out the possibility of both a myocardial infarction and a pulmonary embolism. She was felt to be suffering from hypovolemic shock. An ultrasound was ordered, which showed an abdominal hematoma. General Surgery was consulted, and she was taken back to the operating room where an aortic injury was found and repaired. Postoperatively, she spent two days in the ICU and was then transferred to the floor. She developed a fever on postoperative day #5, which was felt to be secondary to atelectasis. She responded to antibiotics and pulmonary care, and ultimately she was discharged on postoperative day #8.

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Findings of Fact: *Codes: AD=Admission; HP=H&P; DC=Discharge Summary; ER=Emergency Department;

C=Consult; OP=Operative or Procedure Report; PN=Physician Progress Note; PO=Physician

Order; L=Lab; N=Nursing Note; R=Radiology; A=Anesthesia; P=Pathology Report; T=Therapy; PR=Reviewer review of imaging studies

Date Time Code* Finding

06/29/09 HP Attending physician H&P describes a 76-year-old G7P7 female

on unopposed estrogen with postmenopausal bleeding. It appears that an ultrasound was ordered, but no results were

reported. There is no mention that an endometrial biopsy was

done. She was scheduled for a robotic total laparoscopic hysterectomy and bilateral salpingo-oophorectomy.

07/07/09 09:23 OP Attending physician operative note describes an attempted

robotic hysterectomy. Vaginal manipulators and four trocars were placed. The patient then became hypotensive and

unstable. The procedure was terminated. The surgeon believed that the patient may have suffered a myocardial

infarction. No identification or search for injury was described.

07/07/09 PN Attending physician brief postop note indicates procedure was terminated secondary to patient hypotension, records minimal

estimated blood loss for the procedure, and states the patient suffered a presumed myocardial infarction.

07/07/09 10:34 C Consult note: Evaluated the patient immediately

postoperatively in the PACU. Based on his assessment, he does not believe the patient suffered an MI or PE. He noted

the patient’s hematocrit had dropped from 31 preoperatively

to 24 postoperatively, and suspects the patient is suffering from hypovolemic shock. An abdominal ultrasound is ordered.

07/07/09 11:05 R Limited abdominal ultrasound describes a density beneath the umbilicus which likely represents a poorly defined hematoma.

07/07/09 13:24 C General Surgery consult note describes patient’s current status

post aborted robotic hysterectomy, now hypotensive on Neo-Synephrine, and blood transfusions. Abdominal ultrasound

suggests an intra-abdominal hematoma. Patient is consented

for an exploratory laparotomy with the suspicion of a major vascular injury.

07/07/09 13:30 OP General Surgery operative note describes the identification and repair of a puncture wound on the abdominal aorta, on

the right side, just proximal to the bifurcation of the common

iliac arteries. The remainder of the abdomen was free of injury. She received 6 U PRBC and 3 U FFP, and a 3-liter

hematoma was evacuated.

07/07/09 16:48 PN ICU attending admit note reports patient admitted to ICU after surgery in stable condition.

07/08/09 08:27 R Chest x-ray shows dense consolidation of the left lower lung base.

07/12/09 07:24 R Chest x-ray shows improving bilateral basilar effusions with

improving atelectasis.

07/15/09 11:12 DC Attending physician discharge summary describes hospital course with aborted robotic hysterectomy attempt, followed

by subsequent exploratory laparotomy, repair of aortic injury,

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and evacuation of abdominal hematoma. The patient spent

two days in the ICU and was then transferred to the floor. On

postoperative day #5 she developed a fever of 101° F. This was felt to be secondary to pulmonary atelectasis. She

responded to intravenous antibiotics and pulmonary care, and was ultimately discharged home in good condition on

postoperative day #8.

Discussion: This patient was a 76-year-old female with post-menopausal bleeding. The typical work-up for this condition includes both an ultrasound and an endometrial biopsy; if this work-up was done, it was not documented in the medical record. An endometrial biopsy should have been performed because the patient was on unopposed estrogen, which increases the likelihood of endometrial cancer. A combined work-up of an ultrasound and an endometrial biopsy determines whether the bleeding is from either a cancerous or a benign source. If post-menopausal bleeding is from a benign source, a hysterectomy would not necessarily be indicated. This patient had seven vaginal deliveries and was post-menopausal. Based on this history, a vaginal hysterectomy could have been performed. However, it is generally recommended that the ovaries be removed at the time of hysterectomy in a post-menopausal patient; it is mandatory when the patient has endometrial cancer. Use of a laparoscopic approach (whether conventional or robotic) can facilitate ovarian removal. Aortic injury is a known risk of laparoscopic surgery. It is surprising, but not impossible, that there was no obvious blood loss at the time of the initial procedure, as documented in the attending physician’s operative note. Following the initial surgery, the complication was appropriately diagnosed and treated, and the patient had no unexpected complications during her recovery period. Client Concerns or Questions: Questions from the client cover letter are addressed below: 1. Was the procedure indicated for this patient? It is unclear whether the procedure was indicated because the suspected reason for

the patient’s post-menopausal bleeding was not identified by the attending physician in the H&P. The patient was on unopposed estrogen, which is a risk factor for endometrial cancer. However, post-menopausal bleeding for benign conditions does not necessitate a hysterectomy, and there was no indication that the procedure was being performed for a cancerous condition.

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2. Was the use of the robot appropriate for this patient and the procedure? In a post-menopausal patient with seven prior vaginal deliveries, there are many

options for operative technique. A vaginal approach with laparoscopic assistance is one option. It is not necessarily inappropriate to use a robotic approach, but there are less expensive technologies that could have been used.

3. Was the management of the complication appropriate? Following the initial surgery, the complication was appropriately diagnosed and

treated. 4. Please assess the technique and its impact on the patient: I am most concerned about the lack of documentation regarding the indication for a

hysterectomy. Based on the documentation, it is possible that the patient had a benign condition (such as an endometrial polyp) which could have been removed instead by hysteroscopy. A trocar injury may occur during any type of laparoscopic surgery. However, if the hysterectomy was unnecessary, the patient clearly would not have suffered the aortic injury. Assuming the patient had an indication for hysterectomy, use of a laparoscopic technique can be helpful to assist in ovarian removal. Robotic surgery is a form of laparoscopic surgery. However, given the patient’s history, it seems likely that either a laparoscopically-assisted vaginal hysterectomy or a total vaginal hysterectomy would have been a reasonable approach instead of a robotic approach. Choice of operative approach is often determined by the preference and experience of the surgeon.

Conclusions:

I. Documentation Excellent Acceptable X Deficient Grossly Deficient Commentary: The chart was well documented, except the indication for hysterectomy. The stated indication of post-menopausal bleeding is not specific enough to determine whether a hysterectomy was indicated.

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II. Assessment of Care Determination related to standard of care not

possible

Standard of care met

Documentation is incomplete, standard of care

was likely met

Documentation is incomplete, standard of care

was likely not met

Minor deviation from standard of care

X Deviation from standard of care

Significant deviation from standard of care

Deficiency found in the following:

X Medical/clinical knowledge

Technical and clinical skills

Clinical judgment

Interpersonal skills *

Communication skills *

Professionalism *

*These areas of competency are not typically easily assessed by reviewing a medical record.

Commentary: Based on the documentation present, it is not clear that this patient needed a hysterectomy to address her postmenopausal bleeding. III. Impact of Deviation on Outcome Not applicable; the standard of care was met Unknown No negative impact on the patient’s outcome Possible negative impact on the patient’s outcome Likely negative impact on the patient’s outcome X Certain negative impact on the patient’s outcome

Commentary: The injury was directly related to the attempted hysterectomy. If the hysterectomy was unnecessary, and thus was not attempted, the patient clearly would not have suffered the aortic injury.

J. Jones, MD November 27, 2011

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