In March of 2013, The Doctors Company conducted a study of medical liability claims filed against general surgeons. These claims closed between 2007 and the third quarter of 2012. Events resulting in patient harm occurred in the preoperative, intraoperative, or postoperative phases of surgical care. Studies conducted by CRICO Strategies, Boston, MA, and outlined in their 2009 Annual Benchmarking Report: Malpractice Risks in Surgery, supported this finding. They concluded “Surgeons and their clinical teams are found responsible for errors across the entire surgical timeline—flawed decisions to operate, technical errors in the OR [operating room] and postoperative mismanagement during recovery. Alarmingly, most of the scenarios are preventable.”*
Although there are many risks of patient harm in the preoperative phase (diagnosis and treatment selection) and during surgery, we found that some of the most dangerous risks exist in the postoperative time. These potential hazards included failure to recognize and treat surgical complications on a timely basis and other problematic care provided during patients’ recovery. The postoperative phase of patient care became the focus of our study.
Not all surgical complications evaluated in this study were due to negligence. All general surgery claims were included in this review, regardless of whether expert reviewers found negligence in a particular case. We also looked at care provided that was unassociated with surgical complications.
Study of patient injuries
To understand the adverse outcomes that patients experienced in the postoperative phase of care, we looked at patient injuries and determined the following:
- 46 percent of patients represented in these claims and lawsuits died
- 29 percent experienced postoperative infections (not including abscess)
- 14 percent had a puncture or laceration
- 12 percent required additional surgery
- 12 percent required hospitalization or prolongation of hospitalization
- 9 percent had an amputation or other mobility dysfunction
- 9 percent experienced tissue necrosis
- 5 percent had an abscess
(Note: patients may have experienced more than one adverse outcome such as infection and death, so percentages add up to more than 100 percent. See Figure 1.)
Figure 1. Adverse outcomes
Risks unrelated to surgical procedures were identified in the postoperative period as well. Patients receiving opioids for pain who were not properly monitored suffered respiratory depression, prompting the need for ventilator support, and sometimes resulting in death. Many of these patients had unrecognized obstructive sleep apnea. Immobile patients experienced deep venous thrombosis (DVT), pulmonary embolism, and death. One patient suffered ischemic stroke from heparin-induced thrombosis, a rare but recognized complication of anticoagulant heparin therapy.
Manifestations of problems related to surgical complications occurred in a variety of locations (see Figure 2). Some complications developed after patients had been discharged home following post-anesthesia care. The responsibility then fell to family members or friends to distinguish the symptoms of complications from the normal recovery experience. Physicians were contacted at their offices 31 percent of the time, and patients went to emergency rooms in 3 percent of these cases.
Figure 2. Locations where complications occurred
The remainder of postoperative complications manifested themselves in the hospital setting (66 percent). Patients were in inpatient units (not intensive care units [ICUs]) in 54 percent of these cases, intensive care units in 8 percent, and radiology or special procedure areas in 4 percent of cases.
Events that resulted in claims often were due to delayed diagnosis of deteriorating patients’ conditions. Patients made this allegation in 35 percent of these claims and lawsuits. These postoperative allegations included mismanagement of care following surgery. Patients also alleged improper management of treatment (28 percent), improper performance of operation or procedure (7 percent), delay in return to surgery (4 percent), and improper medication management (4 percent) (see Figure 3).
Figure 3. Allegations leading to lawsuits
Factors leading to claims
Physician experts who reviewed these cases for the insurance company identified many of the same issues. For example, “patient assessments” that these experts identified are closely linked to the “delayed diagnosis” allegations. The following are the five factors that physician experts most frequently identified as contributing to patient injury:
- Patient assessment issues (36 percent)
- Failure to order diagnostic tests
- Failure to consider available clinical information
- Over-reliance on negative findings when patients continue to experience symptoms
- Patient factors (22 percent)
- Noncompliance with treatment
- Noncompliance with follow-up call or appointment
- Miscommunication among medical professionals (18 percent)
- Regarding patient’s condition
- Failure to read medical record
- Technical performance (14 percent)
- Complication not due to negligence
- Poor technique
- Retained foreign body
- Misidentification of anatomical structure
- Communication between patient and/or family and surgeons (11 percent)
- Risks of medications
- Poor rapport (unsympathetic response to patient)
- Issues concerning patient care in the hospital
- Follow-up instructions
(Note: Reviewers frequently identified more than one factor that contributed to patient injury, so the percentages add up to more than 100 percent.)
The most common issue that physician reviewers identified was inadequate assessments of patients with postoperative complications. The most frequent assessment issue was failure to order diagnostic tests. Scans of vascular grafts, computed tomography (CT) scans for persistent ileus or to rule out pulmonary embolism, and repeat white blood cell counts to diagnose peritonitis or sepsis were identified as unperformed to identify a complication.
The second and third most common assessment deficiencies were failure to consider available clinical information and over-reliance on negative test results when patients continued to experience symptoms. Examples are as follows:
- In several cases, patients complained of back pain and numbness or loss of control of lower extremities. Later, CT scans revealed spinal epidural abscesses. The experts opined that neurological consults should have been done earlier to prevent the neurological deficits.
- Failure to identify the cause of leg pain in a timely manner resulted in delayed diagnosis of DVT, which led to pulmonary embolism; occlusion of aortofemoral bypass grafts resulted in amputation. Cerebrovascular accidents occurred secondary to anticoagulation therapy or diffuse cerebral hypoxia from bilateral thrombi of sinus veins (rare Factor VIII elevation).
- Assessment of a patient with free air in the abdomen following colonoscopy should have prompted surgical intervention. The patient suffered shortness of breath, tachycardia, and hypotension. Surgery to repair two holes in the patient’s bowel did not occur soon enough to prevent peritonitis with multisystem organ failure and death. Delay in ordering diagnostic tests was the alleged failure in this case.
Patient behaviors were a factor in 22 percent of these claims. The most common behavior, non-compliance with treatment regimens, may be due to a variety of reasons that we were unable to extract from the data; however, it was clear from the fifth most common factor that communication between patients/families and surgeons was sometimes inadequate. Patients were discharged without a clear understanding of the risks associated with their medications or without adequate follow-up instructions.
Communication among physicians was a factor in patient injury in 18 percent of these claims. For example, inadequate communication between hospitalists and surgeons potentially could lead to patient injury and subsequent claims. The following are examples in which inadequate communication led to claims:
- In one case, the general surgeon removed a pelvic mass from a middle-aged woman. The mass was a papillary serous cystic tumor of the ovary. After the mass was removed, the surgeon discharged the patient with no referrals for follow-up. The surgeon should have referred the patient to a gynecologist/oncologist because these tumors require close, long-term follow-up due to the potential for recurrence.
- Multiple cases involved chest X-ray films with incidental findings of lung or mediastinal masses that went untreated. Claims resulted from surgeons’ failure to notify the patients or refer them to other specialists, diminishing their opportunities for positive outcomes.
- In another case, nurses attempted to notify a surgeon of a hematoma following inguinal hernia surgery but were unsuccessful for several hours. The hematoma impinged on the blood supply of one testicle causing ischemia and resulting in an orchiectomy. This raised several questions regarding surgeon availability, surgeon back-up, and the internal chain of command.
- A patient with a colon mass had a right hemicolectomy. Prior to discharge, the patient spiked a fever of 101° F. The nurses did not notify the surgeon. A few days later, the patient was admitted to emergency department in cardiac arrest. The autopsy showed gangrene at the site of the anastomosis with perforation and peritonitis.
- A patient’s incarcerated hernia was repaired with no apparent injury to the bowel. The patient’s vital signs deteriorated, and nurses placed calls to the surgeon. The surgeon provided orders but did not assess the patient. The patient arrested and was resuscitated before being returned to the OR. The bowel was found to be necrotic with multiple perforations. The patient expired due to septic shock.
Technical performance was a factor in 14 percent of these general surgery claims and the fourth most common factor contributing to patient injury. In 62 percent of the claims involving technical performance, the resulting complications were not due to surgical negligence; they were known risks of the procedure. However, when health care professionals failed to recognize and address these complications in a timely manner, they become the basis of a medical liability claim.
Surgeons sometimes found themselves involved in a claim when patients experienced known complications. Even when complications were managed appropriately, some patients felt that their care had been substandard. In these situations, it is of paramount importance that surgeons talk with patients about their surgical outcomes and prognoses. Surgeons need to clarify for patients the reasons for their current condition. Surgeons also need to link the preoperative consent discussion with the complication that patients experienced. Although patients may have difficulty remembering the substance of that earlier discussion, informed consent documents, office notes, and hospital chart notes may help them to recall the conversation. Although patients may still be disappointed with their outcome, this discussion may help them understand and accept it.
Other lessons flow from a review of these cases. Communication and culture are linked and were identified as having an impact on quality of care. Nurses need a safe environment where they are free to talk with surgeons and other specialists when they have concerns about the status of their patients. Their ability to access surgeons must be maintained.
Some hospitals have instituted rapid response teams to support nurses and provide additional assessments. These groups often provide more detailed information to surgeons who then are able to offer an appropriate solution.
Hospitalists are available to assist with patient assessments. They too need open and direct communication with surgeons. Lines of authority for medical management should be discussed and clarified.
Processes for managing incidental findings need to be outlined. Too often the allegation of failure to diagnose malignancies was leveled at surgeons who addressed only the condition that prompted their patient’s operation. Surgeons may not see radiological reports and may be unaware of incidental findings. A process needs to be established for notifying patients of concurrent conditions and arranging follow-up care so these conditions are addressed.
Patients with obstructive sleep apnea need to be monitored when receiving opioids and those at risk for DVT need to be treated prophylactically. System breakdowns were identified for patients who had not been diagnosed with sleep apnea and with known sleep apnea patients. Patients need to be screened for sleep apnea, prior to surgery, and known sleep apnea patients need to be monitored when receiving opioids.
Patients who are identified as being at risk for DVT need to be treated prophylactically. Systems must be in place to notify physicians if nursing assessments flag a patient and protocols need to be adopted to prompt prophylactic treatment unless contraindicated.
Surgeons’ offices must be ready to respond to calls from patients who have been discharged to their homes following surgery. In some cases, calls were mishandled or the message to the surgeon was delayed.
Advances in the art and science of surgery have resulted in what was only a dream cure yesterday becoming the reality of today; however, complications in the delivery of surgical care can occur, and it is important to distinguish unavoidable complications from those due to error.
With good communication and informed consent, patients are more likely to accept unavoidable complications. Complications due to error can be reduced to a minimum or eliminated by carefully studying the root cause and then instituting fail-safe measures to prevent occurrence. The postoperative period is a ripe source of complications that lends itself to corrective action. The postoperative period is an area worthy of study to prevent injuries that would otherwise be avoided by patient safety measures and risk management.
*Ruoff G. 2011 Annual Benchmarking Report: Malpractice Risks in Surgery. CRICO Strategies. Available at: www.rmfstrategies.com/Products-and-Services/Comparative-Data/Annual-Benchmark-Reports#Surgery. Accessed April 17, 2013.