CME Information

Sponsored by:
The NORCAL Group of companies includes NORCAL Mutual Insurance Company, along with its subsidiary companies Medicus Insurance Company, FD Insurance Company, NORCAL Specialty Insurance Company and its affiliate Preferred Physicians Medical RRG.

NORCAL Mutual Insurance Company is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

For questions, please call the Risk Management Department at 855.882.3412.

Method and Medium

To obtain CME credit, read the article then take the quiz and fill out the evaluation form. You can print or email your CME certificate from this application.

Please complete and submit the online quiz by the expiration date indicated below:

Original Release Date: June 15, 2018

Expiration Date: July 1, 2020

Learning Objectives

By reviewing medical professional liability claims and/or emerging topics in healthcare risk management, this enduring material series will support your ability to:

• Assess your practice for risk exposures.
• Apply risk management best practices that increase patient safety and reduce medical professional liability claims.

Target Audience

All physicians, clinicians, staff and healthcare administrators.

Credit Designation Statement

NORCAL Mutual Insurance Company designates this enduring material for a maximum of 1 AMA PRA Category 1 Credit^TM. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Disclosure Policy

As an ACCME accredited provider, NORCAL Mutual Insurance Company requires planners, reviewers or authors who influence or control the content of a CME activity to disclose financial relationships (of any amount) they have had with commercial interests associated with this CME activity during the year preceding publication of the content.

Any identified conflicts of interest are resolved prior to the commencement of the activity.

Disclosures

Individuals involved in the planning, reviewing or execution of this activity have indicated they have no relevant financial relationships to disclose.

NORCAL Mutual professional liability claims closed from 2010 to 2017 were analyzed for emerging trends. The analysis uncovered increased frequency in claims involving chronic viral hepatitis. In the United States, viral hepatitis is most commonly caused by hepatitis A virus (HAV), hepatitis B virus (HBV) and hepatitis C virus (HCV). Acute infection with HBV and HCV can lead to chronic infection. Chronic hepatitis infection is a major risk factor for liver cancer, the incidence of which has been on the rise since the 1980s.¹ HBV and HCV are similar in that individuals with chronic infections are often asymptomatic and are unaware of their infection status.^2,3 These patients often learn of their hepatitis diagnosis when they present with hepatitis-induced cirrhosis or liver cancer.⁴ Some of these patients may blame their physicians for failing to diagnose and treat the hepatitis before it caused liver cancer. Although allegations in HBV and HCV lawsuits can be similar, there are various differences in the epidemiology, disease progression and treatment and monitoring protocols for HBV and HCV. For example:

HCV^4,5,6,7

• Prevalence: 2.7-3.9 million people in the United States have chronic HCV infections.
• Deaths per year: Approximately 20,000 deaths are related to HCV.
• Liver cancer risk: HCV causes approximately 20% of liver cancers.
• Patient demographic mostly affected: Members of the baby boomer generation (individuals born between 1945 and 1965) are five times more likely to have HCV than other adults.
• Vaccination: HCV vaccination is not available.
• Cure: With antiviral treatment, chronically infected individuals can achieve a viral load low enough to be considered cured of the disease. However, being cured of HCV does not entirely remove the risk of developing liver cancer. Depending on the patient's liver health and other liver cancer risk factors, monitoring for liver disease/cancer may continue to be appropriate, even after the patient is cured of HCV.

HBV^{2,5,8,9,10,11,12}

• Prevalence: 850,000 to 2.2 million people in the U.S. have chronic HBV infections.
• Deaths per year: Approximately 14,000 deaths are related to HBV.
• Liver cancer risk: HBV causes approximately 45% of liver cancers.
• Patient demographic mostly affected: Approximately 70% of individuals with chronic HBV infection are foreign-born; most are from Africa, Asia and the Pacific Islands. People born in countries where HBV is common were typically infected at birth or in early childhood.
• Vaccination: Infants in the U.S. have been vaccinated against HBV since 1991, but only 25% of U.S. adults had been vaccinated for HBV in 2014.
• Cure: Treatment can decrease viral load to a point where the disease is no longer causing liver damage, which in turn can reduce the risk of liver damage and cancer, but currently there is no "true" cure. Depending on the patient's liver health and other liver cancer risk factors, monitoring for liver disease/cancer may continue to be appropriate, even after the patient achieves sustained BsAg sero-clearance.

These differences between HCV and HBV should be considered when developing screening, diagnostic testing, treatment and monitoring policies and protocols.

Claims involving hepatitis may be increasing because of a combination of factors. Most importantly, the incidence of liver cancer is increasing.¹³ The increase in the rate of liver cancer is most pronounced in members of the baby boomer generation, who also account for most HCV infections.¹⁴ The increase in liver cancer within this generation is linked mainly to the spread of HCV infection in the '60s, '70s and '80s. Because HCV infection is often symptomless and the progression from HCV infection to liver cancer is slow and typically not detected until it is in advanced stages, physicians are now seeing the results of infections that occurred 20 to 40 years ago. Only 12.3% of baby boomers have been screened for hepatitis.¹⁵

Most of the NORCAL closed claims reviewed for this article involved HCV, although the claims involving HBV had similar allegations. In these claims, either the physician failed to diagnose hepatitis or failed to monitor the patient with a diagnosed case of hepatitis for liver damage, both of which progressed to incurable liver cancer. Both types of cases typically involved follow-up failures. Therefore, the risk management strategies in the following case studies focus on different aspects of follow-up.

Case One

Allegation:

Delayed notification of a positive HCV result caused the patient to suffer cirrhosis of the liver, which necessitated a liver transplant.

The patient presented to the hospital with stomach pain, nausea, blurred vision and migraine. A hepatitis panel was among the tests the ED physician ordered. The patient was treated for pain and nausea and discharged with directions to follow up with her primary care physician. Results indicating the patient had chronic HCV were delivered to the hospital by an outside lab following the patient's discharge. The fact that a hepatitis panel was ordered and outstanding was neither communicated to the patient nor included in the discharge summary. Because the hospital records provided to the patient's family practitioner (FP) did not include the positive HCV result, the FP was unaware of the patient's positive HCV status. Over the next six years, the FP treated the patient for various health concerns unrelated to HCV. When she presented to the ED six years after the positive result, she was advised of her condition.

The patient confronted hospital administrators about the delay in communicating the positive HCV results to her. The administrators informed her that the hospital had no obligation to report test results directly to her because the hospital had reported the results to her FP. However, when the patient obtained her records from her FP's office, there were no hepatitis results, and the FP denied ever being informed of the results.

At the time the lawsuit was filed, the patient was suffering from hepatic cirrhosis and portal hypertension. She was awaiting a liver transplant.

Experts believed the standard of care required the hospital to report the hepatitis result to the patient or her FP. Because of systems issues, the result was not communicated to either party. It wasn't until the litigation of this matter that the hospital discovered it had no protocol for notifying patients or their primary care physicians (PCPs) of lab results received after patient discharge. The hospital policy required only that hospital personnel report critical test results (which included positive hepatitis results) to the ordering physician. In this case, the paper trail ended at the ED. The hospital administrators reported to the patient - and even testified - that its policy was to communicate test results to a patient's primary care physician; however, nothing in the hospital's or FP's documentation supported the contention that the hospital had communicated results to the FP. The hospital's inaccurate testimony about its own policies/protocols, and its inability to substantiate claims of communicating the results, complicated the defense of the claim against it. This was also a case in which a well-organized disclosure discussion most likely would have resulted in a better resolution. Immediately and flatly denying any responsibility for the delays in diagnosis and treatment most likely contributed to the patient's decision to file the lawsuit. Had hospital administrators discussed the matter with the PCP, reviewed hospital policies and documentation prior to stating its position to the patient, and followed an unanticipated outcome disclosure procedure, the resolution of this claim could have been less disruptive to all parties involved. More information about disclosing unanticipated outcomes is available in the NORCAL Resource Document entitled: "Disclosure of Unanticipated Outcomes" and in the November 2017 Claims Rx entitled: "Responding to Unanticipated Outcomes: First Conversations."

Case Two

Allegation:

Delayed notification of a positive HCV result caused the patient to suffer cirrhosis of the liver, which resulted in liver cancer.

A new patient presented to a family practice clinic complaining of abdominal pain and bloody emesis. The PA who examined the patient ordered various tests, including a hepatitis panel. It was the PA's practice to inform patients of results, but she also requested that patients call the clinic if they did not hear from her. A week after the initial appointment, the clinic received the patient's lab report indicating the patient had chronic HCV. The patient did not call for his results, and the medical record contained no indication that the PA advised the patient of the results. Three years later, the PA received notification that the patient had been diagnosed with metastatic liver cancer. He sued the PA, her supervising physician and the clinic for delayed diagnosis and treatment of the HCV, alleging earlier diagnosis and treatment would have decreased his risk of developing liver cancer.

According to experts, the standard of care required that the PA or her supervising physician communicate the positive HCV results to the patient and recommend further testing and/or a consultation with a gastroenterologist. This would have been the PA's standard practice, but she admitted that this patient's results likely "fell through the cracks."

Healthcare risk management and patient safety depend in part on defenses, barriers, and safeguards that protect patients from adverse outcomes. In his article on systems approaches to error management, James Reason refers to defensive layers that ideally would be solid, but are full of holes, like Swiss cheese. In Reason's model, the holes in the Swiss cheese continually open, shut, and shift their location.¹⁹ A patient safety hazard that makes it through one hole in the defensive barrier (e.g., the patient's results are not sent from the lab), is often blocked by a subsequent defensive barrier (e.g., the patient has been told to call the office if she has not received her results and she does call to get her results). If the patient does not call, the hazard can slip through a hole in that barrier. The third barrier might be the office "tickler" system. The hazard stops there if the person in charge of the tickler system notices that there are outstanding test results and follows up with the lab. If there is no tickler system, or if the tickler system is not effective, the hazard moves another step closer to causing injury to the patient. The key is to put effective barriers in place and, if a patient is injured, to figure out where the barrier failed and how to remedy it.

James Reason's Swiss Cheese Model¹⁹ showing how defenses, barriers, and safeguards may be penetrated by an accident trajectory in a failure to diagnose liver cancer claim.

Case Three

Allegation:

Improper monitoring and treatment of HBV and cirrhosis resulted in delayed diagnosis and treatment of liver cancer.

As a child in South Africa, the patient was infected with HBV, but had been asymptomatic his entire life. In 2013, he became a patient of a family practice physician. He did not tell the physician that he was infected with HBV. In preparation for a complete physical, the FP ordered blood tests. The results indicated a 52 SGOT level (N:≤40). The FP asked a staff member to contact the patient for a repeat blood test with a hepatitis panel. A message was left for the patient, but no follow up tests were scheduled. The FP treated the patient on various other occasions through 2014 and 2015, but the hepatitis panel was never completed. In 2016, blood and lab work were ordered again, but without a hepatitis screen. Results reflected 60 SGOT level (N:≤40). The FP again indicated the necessity for follow up with a hepatitis panel, but the patient was never contacted. During a hospitalization for lower abdominal pain in 2017, the patient was diagnosed with stage III liver cancer. He died shortly after he was diagnosed.

According to experts, on the two occasions blood test results were returned to the FP, the SGOT levels were not alarmingly high, but the FP was still obligated to follow up. The fact that he requested hepatitis panel follow-up indicated that he appreciated the abnormalities. The lack of documentation regarding follow-up efforts further complicated the defense. Although the physician testified he would have instructed his staff to advise the patient of the need for follow-up, there was nothing documented. His suggestion that the patient likely refused to be tested for hepatitis could not be substantiated. The FP's defense was further complicated by his failure to address the ongoing need for the testing during the patient's treatment of multiple unrelated conditions throughout 2014 and 2015. There was no indication in the medical record that the FP discussed the need for the hepatitis panel, or that he advised the patient of the risk of foregoing the testing. Had the HBV status been discovered, his liver health could have been monitored and he could have been started on antiviral medications, which likely would have improved his chances of survival. The fact that the patient did not mention to the FP that he had been infected with HBV in childhood did not excuse the FP's failure to follow up on the patient's abnormal liver values. Furthermore, because the patient was born in Africa, a country with an HBsAg seroprevalence of ≥ 2%, the FP should have automatically screened him for HBV, according to various guidelines.12

Case Four

Allegation:

The gastroenterologist was negligent for failing to monitor the patient for liver cancer during and after antiviral treatment for HCV. If the patient had been properly monitored, his liver cancer would have been discovered at a curable stage.

In 2013, a patient was referred by his FP to a gastroenterologist (GI 1) following elevated liver function results. GI 1 ordered a hepatitis panel, which indicated the patient had chronic HCV. He then ordered a CT scan and liver biopsy. The results indicated the patient had advanced fibrosis (METAVIR stage F3). The CT scan was equivocal for cirrhosis. GI 1 recommended treatment with antivirals.

Prior to the start of treatment, the patient moved to a different state. In 2014, the patient started antiviral treatment with GI 2. The patient provided GI 2 with his past medical records. By 2015, sustained virologic response (SVR) was achieved and his liver enzymes had normalized. He was discharged from GI 2's care with instructions to follow up as needed.

During a 2016 ED visit for a suspected myocardial infarction, a large mass was discovered in the patient's liver. He was diagnosed with moderately differentiated liver cancer induced by HCV and HCV cirrhosis. The size and vascularity of the lesion precluded surgery.

According to experts, because the patient had advanced fibrosis he should have been monitored with alpha-feto protein testing and surveillance imaging of the liver for the development of liver cancer during and following HCV treatment. GI 2 admitted during litigation that he had either overlooked the liver biopsy report in the patient's transferred medical records or failed to appreciate the need to monitor the patient for liver cancer. He admitted that the standard of care required doing so.

Follow-up failure is a frequent cause of patient injuries that results in malpractice lawsuits. The timely diagnosis and treatment of chronic hepatitis and hepatitis-induced liver cancer relies heavily on appropriate screening, monitoring and test result follow-up. There are abundant tools available to aid in the screening, diagnosis and monitoring process, but systems must be in place to ensure the tools are used appropriately and to their greatest advantage. Everyone makes mistakes. It is important to anticipate which types of mistakes are likely, and then create barriers to keep those mistakes from causing patient injury. The risk management strategies introduced in this article can create the type of redundancy in follow-up systems that support timely diagnosis and treatment of hepatitis before it progresses to liver cancer.