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: July 15, 2018

Expiration Date: August 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 cervical cancer. The increase in claims frequency does not appear to be tied to cervical cancer incidence. Although one of the most prevalent cancers affecting women - in 2018, there will be an estimated 13,240 women diagnosed with cervical cancer in the United States, causing an estimated 4,170 deaths - cervical cancer rates have been flat for the past approximately 25 years,¹ and early research indicates that the HPV vaccination is reducing cervical cancer incidence.²

The majority of NORCAL failure-to-diagnose cervical cancer closed claims involve failure to follow up on some aspect of cervical cancer screening. NORCAL cervical cancer claims were almost twice as likely to pay indemnity compared to all claims during the same period (52% vs 27%). The high indemnity percentage could be attributed to the existence of fairly detailed clinical guidelines and algorithms for cervical cancer screening, which support plaintiffs' arguments that the standard of care was not met. As the following case studies illustrate, these guidelines are not followed for various reasons. These failures may be associated in some part with the complexity of the screening and follow-up guidelines and the multiple guideline changes that have occurred over the past decade.³

Case One

Allegation:

Incorrect follow-up directions resulted in delayed diagnosis of cervical cancer.

A 37-year-old patient had undergone "well-woman" exams with a family practice physician (FP) for the past 10 years on a mostly annual basis. Her cervical cancer screenings had been normal until 2011, when her cervical cytology was negative, but her human papillomavirus (HPV) was positive. Her FP advised her to return in one year for follow-up testing. In 2012, her cytology was negative and HPV was positive. According to her medical record, she was informed of her results and told to return for repeat testing in one year. (In fact, the guidelines in place at the time recommended colposcopy.) She had episodic appointments with her FP in 2013, 2014 and 2015. She was not screened or offered a colposcopy at any of these appointments. In 2016, she was diagnosed with metastatic cervical cancer.

The patient alleged in her lawsuit that the three-year delay in the diagnosis and treatment of cervical cancer decreased her life expectancy and necessitated extensive surgery, which resulted in complications and permanent disabilities.

The failure to diagnose cervical cancer in this case had various contributing causes. For example, experts were in agreement that the standard of care required the FP to recommend a colposcopy following the patient's second positive HPV result. The FP acknowledged his error. He thought either he failed to appreciate that two consecutive HPV tests had been positive, or his office was lagging behind in implementing the newest cervical cancer screening guidelines. In addition, the FP failed to follow up on the erroneous one-year testing recommendation in 2013 and thereafter, even though the patient was in the office on numerous occasions while her cervical cancer allegedly metastasized. In deposition, the patient claimed she was unaware of the second positive HPV result. She believed she was due for another cervical cancer screening three years from her 2012 screening, which would have been the appropriate timeline if her HPV test had been negative.4 The patient assumed the best and relied on her FP to make recommendations for screening. Had her FP acknowledged and discussed the abnormal results during any of her appointments between 2012 and 2105, the mistake in follow-up recommendations might have been recognized.

Case Two

Allegation:

Delayed diagnosis of cervical cancer reduced the patient's life expectancy.

A 30-year-old patient presented to her FP for her first prenatal visit. The FP collected a specimen for cervical cytology/HPV analysis, and it was sent to an outside laboratory. The results - AGC-NOS (Atypical Glandular Cells-Not Otherwise Specified)/HPV negative - were routed to an RN in the office who was tasked with managing all cervical cancer screening test results. The nurse's process for managing the results was fairly simple. When she obtained an abnormal result, she would use the American College of Obstetricians and Gynecologists/American Society of Colposcopy and Cervical Pathology abnormal cervical cytology/HPV results algorithms to figure out the follow-up plan, which she would then note on the test result report. Once she had made a plan, she would call the patient to report the results and schedule follow-up. Until the patient was scheduled for a follow-up appointment, the nurse kept the patient's record on her desk. Once the follow-up appointment was made, she returned the patient's record to the file room.

In this case, the nurse noted on the result report that the follow-up plan was to repeat cytology at the first post-partum appointment. The algorithms did not provide guidance for pregnant patients with AGC-NOS results and the nurse mistakenly believed colposcopies were not appropriate for pregnant patients, which is why she documented the plan to follow up post-partum. She called the patient two times to communicate the results. Following the second attempt, she left a message for the patient to call back to get her results. The patient did not return the call and, at some point, the patient's medical record was removed from the nurse's desk, presumably for one of the patient's prenatal appointments. Although the nurse was uncomfortable with her assigned task of treatment planning for abnormal screening results, she assumed a physician would review her plans and revise them if necessary.

The patient was followed throughout the remainder of her pregnancy by various physicians in the practice. No one discussed the markedly abnormal cervical cytology results with her. Each physician assumed the follow-up was being managed by someone else. At her post-partum follow-up appointment cervical cytology was not repeated. She returned two years later complaining of cramping and abnormal bleeding. She was ultimately diagnosed with stage IIIB cervical cancer. She filed a lawsuit against the group and all of the physicians who had examined her, alleging negligent delay in the diagnosis of cervical cancer.

According to the experts, an AGC-NOS result requires immediate colposcopy, regardless of whether the patient is pregnant. Independent of the colposcopy requirement, the patient needed to be advised of the cytology results. Although this case involved a nurse who was practicing with a degree of independence that might not have been appropriate, and it would be easy to place the majority of blame on her for the patient's injury, there were many different root causes of this missed diagnosis. First, she should not have been tasked with interpreting test results and planning follow up care - that was an administrative and leadership problem. Second, experts believed each physician who examined the patient during her pregnancy shared the responsibility of informing her about and recommending appropriate evaluation of the abnormal cytology results. At the very least, the results of the cervical cancer screening should have been reviewed by the physician who ordered it, and he should have made a decision about how to manage it. In a practice where the clinicians take a team approach to patient care, special attention must be directed towards responsibilities for follow-up on test results. Finally, there was no process for confirming that the patient received the information. Leaving a message with the patient to call the office to receive test results was not enough.

Case Three

Allegation:

The OB/GYN failed to advise the patient of an abnormal cervical screening result in a timely manner, which resulted in delayed diagnosis and treatment of cervical cancer.

On October 16, 2013, a 40-year-old patient presented to an OB/GYN for a well-woman exam and was screened for cervical cancer. Before she left the office, she was scheduled for a test result follow-up appointment. Two weeks later, the OB/GYN received the results, which were abnormal and required immediate follow-up with colposcopy. The OB/GYN tasked her MA with notifying the patient of the results and scheduling a colposcopy. Later, the patient cancelled her appointment to discuss test results and did not reschedule.

Two years later, the patient presented for a well-woman exam. The OB/GYN asked the patient why she had not presented for a colposcopy. She then realized the patient was unaware of the abnormal result. The patient was ultimately diagnosed with stage IVA cervical cancer.

The patient filed a malpractice case against the OB/GYN, alleging she and her staff were negligent for failing to notify her of the abnormal result and the need for colposcopy, which would have resulted in her cancer being diagnosed and treated.

The medical record documentation indicated the MA was unable to reach the patient on two consecutive days following receipt of the abnormal results and therefore mailed a letter informing the patient of the abnormal results and the need for colposcopy. During the litigation of the case, however, the MA admitted to adding the back-dated entry to the patient's record after she learned about the lawsuit. She adamantly maintained that she had simply forgotten to document the communication attempts at the time they had occurred and had attempted to make an adequate record. Unfortunately, the damage to her credibility was done when she added the backdated note to the record. Furthermore, although office policy required placing a copy of patient letters communicating test results in the patient file, there was no copy of the letter in this patient's record. All these facts taken together made it difficult to disprove the patient's allegations of never having been informed of the results or the need for follow-up. The OB/GYN shared responsibility for the patient injury because her practice had inadequate administrative systems in place to ensure patients received their test results.

Any clinician offering cervical cancer screening needs to manage the results appropriately, which can be complicated. Guidelines on cervical cancer screening are issued by numerous organizations. Guideline recommendations are mostly consistent, but they regularly shift and change. For example, in May 2012, the American Cancer Society (ACS), American Society of Colposcopy and Cervical Pathology (ASCCP), and American Society of Clinical Pathology (ASCP) issued joint cervical cancer screening guidelines. Later that year, the U.S. Preventive Services Task Force (USPSTF), and then the American Congress of Obstetrics and Gynecology (ACOG), released guidelines that were consistent with the joint guidelines. In 2105, the American College of Physicians (ACP) issued guidelines for average-risk women, which were supported by ACOG and endorsed by ASCP. The same year, the Society of Gynecologic Oncology (SGO) and ASCCP published interim clinical guidance for primary high-risk HPV testing for cervical cancer screening. Most recently, in September 2017, USPSTF released draft cervical cancer screening recommendations and evidence review for public comment.⁷ At the time of this article's publication, the finalized USPSTF guidelines had not been released. (Directions for accessing these guidelines online can be found later in this article.)

The major difference between the proposed USPSTF guidelines and the 2012 collection of guidelines is the recommendation that average-risk women aged 30–65 years be screened either every three years with cervical cytology alone or every five years with high-risk HPV testing alone. Co-testing for this patient cohort is no longer recommended. The preferred approach in the ACOG guidelines for these patients, on the other hand, is co-testing with cervical cytology and high-risk HPV testing every five years, with cervical cytology alone every three years as an acceptable screening strategy. However, according to its website, AGOG is "reviewing the USPSTF draft recommendation statement and the evidence upon which it is based to evaluate the need to update ACOG's guidance on cervical cancer screening." In the interim, ACOG "continues to affirm its current cervical cancer screening guidelines." However, ACOG considers high-risk HPV primary screening an acceptable alternative to cytology-based screening methods if it is performed pursuant to the ASCCP and SGO interim clinical guidance.⁸

Consequently, it may take some effort to stay abreast of the changes in screening and responding to abnormal result clinical guidelines. Office policies and protocols should be revised when guidelines change. Also, it is important to discern whether EHR algorithms and recommendations for screening and responding to abnormal results are consistent with the latest guidelines. Finally, with extended periods between cervical cancer screenings, there will be fewer chances to catch abnormal results that have fallen through the cracks, particularly if patients only present for well-woman visits when cervical cancer screening is due. Some of the missed results will develop into cervical cancer and valuable treatment time will be lost before the next screening. Encouraging patients to follow up for a yearly breast and pelvic exam regardless of the frequency of cervical cancer screening not only allows for evaluation of the other organs, but also provides an opportunity to review the record for previously missed results.

Early identification of cervical cancer and its precursors is the key to optimal treatment of cervical cancer. There are abundant tools available to aid in the diagnostic process. Failure to use these tools appropriately can not only lead to patient injuries, but also can increase liability risk. Understanding the use of these tools is only one aspect of improving patient safety. Another aspect of patient safety is determining why an adverse event occurred and solving the problems that allowed it to occur. There are various tools available to analyze and address an adverse event. The A3 process is a straightforward method of discovering the root causes of adverse outcomes and developing risk management and patient safety solutions.

Finally, many of the patients in these case studies never knew they had abnormal results until cancer was diagnosed. Many of these women did not pursue the results of their screenings when their physicians failed to notify them. They must not have fully appreciated the value of knowing the results. An engaged patient may be more likely to pursue her cervical cancer screening results when the system has broken down elsewhere. Getting patients engaged in the process may require spending extra time on the front end to educate them, but it can pay off when patients are playing an active role in managing their own health.