The Issue in Focus

Cervical cancer screening is an important preventive step that can help detect changes in the cervix before cancers can develop. Screening is critical to reducing mortality: when detected early, the five-year relative survival rate between 2009 and 2015 was 92% for cervical cancer classified as localized by the National Cancer Institute's SEER (Surveillance, Epidemiology, and End Results) database, compared with 17% for cancers detected at the distant stage (3). Still, the American Cancer Society (ACS) estimates 13,800 new cervical cancer diagnoses and 4,290 cervical cancer deaths in 2020 (1).

At one time, cervical cancer was one of the most common causes of cancer deaths among U.S. individuals with a cervix; however, between 1955 and 1992, the incidence and death rates of U.S. cervical cancer declined by more than 60%. This decrease can be attributed largely to the development of the Papanicolaou test (Pap smear or Pap test)—one of the most effective cancer screening tests available (2).

Current professional guidelines include three approaches to cervical cancer screening: human papillomavirus (HPV) testing alone, which detects the presence of certain high-risk strains of HPV in cervical cells; Pap testing alone; and HPV/Pap cotesting, which checks the same cell sample for both high-risk HPV types and cervical cell changes. These methods are discussed in Screening Methods. Additional updates to the guidelines are discussed in detail in Cervical Cancer Screening Guidelines.

When used correctly, these tests can potentially improve the early detection of cervical cancer. However, it is important to recognize that these tests are still imperfect tools designed to screen populations rather than definitively diagnose disease in individuals, and human and systems errors can reduce the reliability of these tests. For example, the Pap test and the HPV test are prone to both false-negative and false-positive results. False positive results can lead to patient anxiety and additional unnecessary expensive diagnostic evaluation and testing, such as colposcopy and biopsy. False negative reports can cause a delay in appropriate follow-up testing and procedures. (6)

In addition, other factors such as test tracking and follow-up, obtaining an accurate patient history, and proper documentation are also important when screening for cervical cancer, as is raising awareness among the community about the importance and availability of cervical cancer screening.

Claims and Litigation

​Ask ECRI
​A member asked about having a nonphysician perform the initial review of test results and file normal test results in patient records without review by the ordering physician. See Ask ECRI: Must a Physician Review Normal Test Results?

When cervical cancer goes undetected, not only can it compromise patient safety, but it can also result in expensive lawsuits, bad press, and unannounced inspections from regulatory agencies for the healthcare facility. In fact, failure to diagnose and delay in diagnosis of cervical cancer are among the most prevalent types of medical malpractice claims encountered in obstetrics and gynecology; additionally, claims alleging a delay in cervical cancer diagnosis are difficult to defend (5). To avoid litigation and provide optimal patient care, it is important that cytology laboratory reports contain clear terminology, a proper interpretation of the Pap smear slide, a clearly stated recommendation by the laboratory, and a proper clinical follow-up by the ordering clinician (7).

Areas of physician and laboratory negligence in cytology malpractice lawsuits can include the following (7,5):

• Delayed or missed diagnosis of cervical cancer
• Failure or delay in ordering diagnostic tests
• Narrow diagnostic focus or failure to establish differential diagnosis
• Improper sampling/scraping or identification (failure to collect and/or find abnormal cells on a slide)
• Failure to address abnormal findings
• Incomplete patient history or failure to follow up with the patient
• Inadequate patient or family education regarding follow-up instructions
• Patient nonadherence with follow-up call or appointment
• Improper Pap smear processing (including identification, staining, and reviewing previous Pap slides)
• Failure to follow up after examining a slide and noting the presence of few abnormal cells, small or cytologically bland cells, or the presence of obscuring factors such as inflammation or blood
• Erroneous interpretation, comments, or recommendations by a cytotechnologist or pathologist; The Doctors Company found that misinterpretation of diagnostic studies occurred in 50% of cervical cancer claims when reviewing closed claims data
• Inexperienced or overworked cytotechnologists
• Inadequate training and supervision of cytotechnologists
• Absence of a quality assurance program
  

Many cases arise when a false-negative result is found on review of a prior Pap smear from a patient in whom cervical cancer was recently diagnosed or when an unsatisfactory smear is not reported as such. These slides may be susceptible to being interpreted differently by various cytotechnologists and pathologists. Experts retained to review questioned slides in the context of litigation generally have the advantage of knowing that the patient subsequently developed cancer. Plaintiffs in these cases typically allege negligence against one or more pathologists or cytotechnologists; additionally, the director of the defendant laboratory and the primary care provider who obtained the Pap smear may be involved in the litigation (7).

For example, in 2012, a Pittsburgh hospital was sued by a patient who alleged that the hospital's pathologist misread her Pap test results for five consecutive years before she received a diagnosis of cervical cancer. A subsequent review of those slides by the hospital's pathologist and by outside pathology experts concluded that those five years of tests showed a clear progression from precancerous cells to invasive carcinoma. In addition, the woman tested positive for HPV in 2006; however, her doctors never followed up with her. The allegations led to a surprise investigation by the Pennsylvania Department of Health, Centers for Medicare & Medicaid Services (CMS), The Joint Commission, and the College of American Pathology and prompted the hospital to turn over 500 Pap test slides from women tested at the hospital from 2006 to 2010 to an outside pathology laboratory for review. The slides represented a sampling of thousands of tests conducted over the same period, and included the five slides from the plaintiff. (8)

In another case, a 52-year-old woman presenting with an enlarged uterus with multiple fibroids and experiencing pain and heavy bleeding from her vaginal area requested a consultation to have a hysterectomy. During the visit, a Pap smear was performed and found by the pathologist and cytotechnologist to be negative for intraepithelial lesion or malignancy and was noted to be within normal limits. Sixteen months later, after experiencing a lump on her right thigh and pain in her vaginal area with irregular bleeding, the patient was again seen and a Pap smear was again performed; these Pap test results showed high-grade squamous intraepithelial lesion and moderate to severe dysplasia. A follow-up colposcopy confirmed that the patient had stage 3 cervical cancer, and she underwent chemotherapy and radiation. The plaintiff alleged that the pathologist and cytotechnologist misread the initial Pap smear, resulting in a 16-month delay in diagnosis and treatment. The case was settled for $1 million. (9)

In a third case, a Maine jury awarded $7.65 million to a woman who alleged that, although she underwent annual vaginal exams, a hospital technician misread her Pap tests for 2009 through 2011, allowing the undetected cervical cancer to progress to stage 3 and causing permanent disfiguring injuries and chronic pain. The cancer was diagnosed only when the plaintiff later saw another physician. The jury also awarded $2 million to her husband for loss of consortium. The nearly $10 million awarded in this case was one of the largest in Maine's history. (10,11)

Disparities in Cervical Cancer Screening

Despite improvements in cervical cancer screening, diagnosis, and treatment, care disparities still exist, and factors such as race, geographic location, and socioeconomic status can affect screening and treatment accessibility as well as mortality. According to the Centers for Disease Control and Prevention (CDC), "More Black and Hispanic women get HPV-associated cervical cancer than women of other races or ethnicities, possibly because of decreased access to screening tests or follow-up treatment." (12) In addition, the five-year overall survival rate for cervical cancer is 66%; however, when examining the results by race, the survival rate is 71% for white women and 58% for Black women. (13) Even greater disparities can exist among these populations depending on the state and geographic area in which they reside and their socioeconomic status (14).

Although cervical cancer death rates overall have declined steadily over recent decades, the American Cancer Society found that non-Hispanic Black women were 80% more likely to die from cervical cancer than non-Hispanic white women (15). One study corrected mortality rates for the prevalence of hysterectomy and to evaluate disparities by age and race and found that cervical cancer mortality rates are underestimated, especially in Black women and, in particularly, older Black women. For Black women, the corrected mortality rate was 10.1 deaths per 100,000, whereas in white women, the corrected rate was 4.7 deaths per 100,000. In Black women ages 85 and older, the corrected rate was 37.2 deaths per 100,000. (16)

These disparities may exist for a number of reasons, including lack of access to cervical cancer screening and cultural differences (e.g., mistrust of the healthcare system). Community-based efforts that improve access to screening and vaccination can help narrow the gap. (17) For more information, see Engage in Efforts to Increase Access to Cervical Cancer Screening.

Treatment disparities may also exist for transgender men, who are at risk for cervical cancer. Such individuals are less likely to be current on cervical cancer screening than cisgender women, and may face challenges obtaining pelvic exams or Pap tests, as well as accessing culturally sensitive healthcare (18). Studies indicate that transgender men have higher rates of abnormal cervical cancer screening results, higher likelihood of not being screened for cervical cancer in their lifetime, and lower likelihood of receiving regular cervical cancer screening compared to cisgender women (19). Cervical cancer screening for transgender men should follow the same schedule as that for cisgender women (18).

Regulations and Standards

The Clinical Laboratory Improvement Amendments

In the aftermath of a wave of lawsuits concerning false-negative Pap test reports, amendments were made to the federal Clinical Laboratory Improvement Act, known as the Clinical Laboratory Improvement Amendments of 1988 (CLIA), through which CMS regulates matters such as qualifications, employee supervision, workload limits, proficiency testing, and quality control in clinical laboratories. Numerous mandates are provided in CLIA regulatory standards for cytology; some of these are discussed in Review Laboratory Policies and Procedures.

CMS has also issued survey procedures and interpretive guidelines for laboratories and laboratory services addressing cytology standards, which are available online from the CLIA website. Risk managers should be aware that CLIA regulations mandate only minimum standards for laboratories and that guidelines from professional organizations may recommend a higher standard. More information can be found on this subject in the guidance article Clinical Laboratory Improvement Amendments. 

Accrediting Agencies

Clinical laboratories can choose to be surveyed by CMS, their state-approved CLIA program, or a private accrediting organization. There are currently seven approved private accrediting organizations (20); laboratories issuing CLIA certificates who choose to be surveyed by private accreditors will receive a certificate of accreditation rather than a certificate of compliance. COLA, formerly known as the Commission on Office Laboratory Accreditation, accredits the most (6,091), closely followed by the College of American Pathologists (6,409) and The Joint Commission (1,995) (21). These accreditors may have more stringent standards than CMS, such as survey and other quality-related requirements for certificate-of-waiver laboratories or point-of-care-testing-related requirements.

For clinical laboratories that have chosen to be surveyed by an accrediting organization, that accreditor is also responsible for investigating all complaints and determining how serious they are. For complaints determined to pose immediate jeopardy—an imminent and serious threat to patient health or a significant hazard to public health—CMS requires that the investigation be initiated within two working days. Complaints may be investigated on-site or through communications between the survey organization and the laboratory. Complaint investigations for all survey organizations are unannounced. (22)

Federal and State Laws

Coverage of cervical cancer screening tests is required under the Patient Protection and Affordable Care Act of 2010. Likewise, Medicaid or public assistance programs in all 50 states and the District of Columbia cover screening for cervical cancer either routinely or on a doctor's recommendation. Medicare beneficiaries are eligible to receive a Pap test, pelvic exam, and a clinical breast exam every two years; women of childbearing age who have had an abnormal Pap test in the previous three years or who are considered high risk for cervical or vaginal cancer are eligible under Medicare to be covered for yearly screening. Part B also covers HPV screening once every five years for individuals ages 30 to 65. (23)

In addition, the National Breast and Cervical Cancer Early Detection Program (NBCCEDP), which is managed by CDC, provides breast and cervical cancer screening to women without health insurance for free or at very little cost. The NBCCEDP is available in all 50 states, the District of Columbia, 5 U.S. territories, and 11 American Indian/Alaska Native tribes or tribal organizations. The program attempts "to reach as many women in underserved communities as possible, including older women, women without health insurance and women who are members of racial and ethnic minorities." If cervical cancer is detected during screening in this program, most states can extend Medicaid benefits to these women to cover the costs of treatment. (24)

Action Plan

Educate Providers about Current Cervical Cancer Screening Guidelines

Action Recommendation: Ensure that primary healthcare providers are aware of current guidelines for cervical cancer screening and that patients are involved in shared decision making concerning care plans.

Screening Methods

There are three approaches to cervical cancer screening: Pap testing alone; HPV testing alone; and HPV/Pap cotesting. Healthcare providers should be well acquainted with these methods, what they test for, and when they are appropriate to use.

The Pap test. The Pap test enables clinicians to detect cervical intraepithelial neoplasia (CIN) so it can be removed before it progresses to cervical cancer. The test also enables detection of cervical cancer at an early stage.

During a Pap test, cells are removed by a healthcare provider (typically a doctor or nurse) by inserting a speculum into the vaginal canal, using a cotton swab to remove excess mucus from the cervical opening, and gently scraping a sample of cells from the cervix. Once the cells are removed, they are prepared for examination using one of two methods:

• In a conventional Pap test, the cells are collected and spread directly onto one or more glass slides, then affixed to the slide immediately, usually with a spray fixative. With this method, cells can sometimes rest in layers, making cells at the bottom difficult to see clearly. In addition, not all cells are transferred onto the slides, slides can be broken during transport, and cells can become damaged before they arrive at the lab for analysis. (25)
• In liquid-based cytology, the cells are placed into a vial of preservative liquid, which helps filter out blood and other potentially obscuring materials and can protect the cells during transport (25). The cells are then processed in a lab. This method produces a more homogenous sample that rests on a single layer on the slide, making cells more clearly visible than in conventional Pap testing. In addition, because only a representative portion of the sample is used, the residual material in the vial can be used for other ancillary testing, such as HPV testing. (26)
  

Pap slides are typically analyzed by a computer-based imager or sent to a cytotechnologist and/or pathologist for review; if no abnormal cells are found, a report describing the findings is made and sent to the referring healthcare provider. If an abnormality is identified, the smear is examined by a pathologist for an independent evaluation. The pathologist describes the nature of the abnormal cells using standardized nomenclature (see The Bethesda System), and a report is sent to the referring clinician.

HPV test. The HPV test detects the presence of certain high-risk strains of HPV, a virus that can cause cell changes that can lead to cervical cancer (27). Genital HPV infection is the most common sexually transmitted infection in the United States. Although most sexually active individuals develop HPV infection, most HPV infections are transient and benign. However, persistent infection with a high-risk type of HPV can lead to the development of high-grade precursors to cancer or cervical cancer if the precursors are not detected through screening and subsequently treated. (28) Two "high-risk" HPV genotypes—HPV types 16 and 18—are responsible for about 70% of cervical cancers worldwide, and the detection of these genotypes using the HPV DNA test can be a good indicator of a person's risk of cervical cancer. (29)

The HPV test is generally performed at the same time as a Pap test using the same swab or a second swab (6).

HPV/Pap cotesting. HPV/Pap cotesting checks the same cell sample for both high-risk HPV types and cervical cell changes. Many guidelines recommend cotesting as the preferred method of screening for cervical cancer in patients older than age 30. (See Cervical Cancer Screening Guidelines for more information.)

Cervical Cancer Screening Guidelines

Healthcare risk managers should take steps to ensure that providers are aware of the latest cervical cancer screening guidelines as well as the facility's policy on how often patients from different populations should be screened. In addition, they should ensure that the medical staff has accepted and approved the guidelines and incorporated them into the facility's policy. Caregivers should also make every attempt to ensure that patients are involved in decisions regarding care plans, particularly patients who are at high risk for cervical cancer and who must therefore be screened more frequently.

ACS, ACOG, and USPSTF have each published and updated cervical cancer screening guidelines focusing on indications and intervals for screening. In addition, a panel of experts from these and other professional organizations released interim guidance after the approval of an HPV test that could serve as a primary screening tool for cervical cancer; however, these guidelines do not replace recommendations in current guidelines. (30)

Professional organizations have modified and updated their guidelines throughout the years regarding screening intervals, when to stop screening, the use of new technology, and the routine use of HPV testing as adjunct to cytology screening. Although cervical cancer screening guidelines have become more consistent across professional organizations in recent years, a 2020 update of the ACS cervical cancer screening guidelines differs substantially from other guidelines by recommending HPV testing as the primary method for screening. Other professional organizations are in the process of reevaluating their guidelines to determine whether they should better align with ACS's guidelines. Healthcare providers must be ready to answer patient' questions and clarify areas where there is no consensus among the various cervical cancer screening guidelines. (30)

American Cancer Society. In 2020, ACS updated its screening recommendations for the prevention and early detection of cervical cancer. As mentioned, the most significant change is that HPV testing is now recommended as the primary method for screening; this is different than past guidelines, where cytology every three years was the preferred method for screening and HPV testing was not recommended as a primary method. The following summarizes the ACS guideline (31):

• Beginning at age 25, all individuals with a cervix should begin cervical cancer screening:
• The preferred method is to undergo an FDA-approved HPV test alone every five years.
• Where access to primary HPV testing is limited or not available, cotesting every five years or cytology alone every three years are acceptable options.
• For individuals with a cervix who are older than age 65, who have had regular screening with normal results, HPV testing should be discontinued. Individuals older than 65 without documentation of prior screening should continue screening until criteria for cessation are met. (Adequate negative prior screening is currently defined as two consecutive, negative primary HPV tests, or two negative cotests, or three negative cytology tests within the past 10 years, with the most recent test occurring within the past three to five years, depending on the test used.)
• Individuals who have had a total hysterectomy (removal of the uterus and cervix) should stop screening, unless the hysterectomy was done as a treatment for cervical cancer or serious precancer. Individuals who have had a hysterectomy without removal of the cervix should continue cervical cancer screening according to the guidelines above.
• Individuals who have had the HPV vaccine should still follow the screening recommendations for their age group.

Individuals who are at high risk for cervical cancer may need to be screened more often, including those with HIV infection, organ transplant, or exposure to the drug diethylstilbestrol (DES). These individuals should consult with their doctor or nurse to determine an appropriate screening interval. (31)

American College of Obstetricians and Gynecologists. In September 2017, ACOG published frequently asked questions for cervical cancer screening. The following is a summary of ACOG's recommended screening guidelines (32):

• All relevant individuals should begin cervical cancer screening at age 21.
• Individuals age 21 through 29 should have Pap tests alone every three years. HPV testing is not recommended for this age group.
• For individuals age 30 through 65, it is preferred that a Pap test and an HPV test (cotesting) be performed every five years. It is acceptable to have a Pap test alone, performed every three years.
• Individuals older than 65, who have no history of moderate or severe abnormal cervical cells or cervical cancer, and who have had either three consecutive negative Pap test results or two consecutive negative cotest results within the past 10 years, with the most recent test being performed within the past five years, do not need to be screened for cervical cancer.
• Individuals should not follow the above guidelines if they have any of the following: a history of cervical cancer, an HIV infection, a weakened immune system, or an exposure to DES before birth. These populations may require additional screening.
• For those who have had a hysterectomy, cervical cancer screening may still be necessary, depending on why the hysterectomy was needed, whether the cervix was removed, and whether the patient has a history of moderate or severe dysplasia.
  

In response to the ACS update of its guidelines, Christopher M. Zahn, MD, FACOG, vice president of practice activities at ACOG, released the following statement (33):

"ACOG looks forward to comprehensively reviewing the ACS recommendations and the supporting evidence in order to determine whether a similar update to our clinical guidance document on cervical cancer screening is needed. In the interim, ACOG affirms our current cervical cancer screening guidelines, which encompass all three cervical cancer screening strategies (high-risk human papillomavirus testing alone, cervical cytology alone, and co-testing). ACOG's current screening guidelines reflect a balance of benefit and potential harms and support shared decision-making between patients and their clinicians."

U.S. Preventive Services Task Force. USPSTF is a federally appointed panel of independent experts. In 2018, USPSTF updated its cervical cancer guidelines. The following is a summary of the guidelines (34):

• All relevant individuals should begin cervical cancer screening at age 21. USPSTF recommends against screening for cervical cancer before age 21.
• Individuals age 21 through 29 should have a Pap test alone every three years. USPSTF recommends against screening for cervical cancer with HPV testing, alone or in combination with the Pap test, in individuals younger than age 30.
• Individuals aged 30 through 65 should be screened every three years with the Pap test alone, every five years with high-risk HPV (hrHPV) testing alone, or every five years with hrHPV testing in combination with Pap testing (cotesting).
• Individuals older than age 65 who have had adequate prior screening and are not otherwise at high risk for cervical cancer should not be screened. However, further screening may be indicated for women older than 65 who have not been adequately screened. USPSTF estimates that approximately a quarter of women aged 45 to 64 have not been screened for cervical cancer in the preceding three years. In particular, women with limited access to care, women from racial/ethnic minority groups, and women from countries where screening is not available may be less likely to meet criteria for adequate prior screening.
• Individuals who have had a hysterectomy with removal of the cervix and who do not have a history of a high-grade precancerous lesion or cervical cancer should not be screened for cervical cancer.
  

USPSTF notes that its recommendations still apply regardless of a person's sexual history or HPV vaccination status. The recommendations do not apply to individuals who have received a diagnosis of high-grade precancerous cervical lesion or cervical cancer, individuals with in utero exposure to DES, or individuals who are immunocompromised, such as those who are HIV positive. (34)

Society of Gynecologic Oncology and the American Society for Colposcopy and Cervical Pathology. In 2015, a panel of 13 experts, including representatives from professional organizations such as the Society of Gynecologic Oncology, the American Society for Colposcopy and Cervical Pathology, ACOG, ACS, the American Society of Cytopathology, the College of American Pathologists, and the American Society for Clinical Pathology, convened to provide interim guidance for the use of hrHPV testing as a primary screening method for cervical cancer. The panel was convened because of "a growing body of evidence for screening with primary hrHPV testing" and the approval of an HPV test that could serve as a primary screening tool for cervical cancer. Based on a literature review and expert opinion, the group developed interim guidance for using the HPV test as a primary screening method. (30) It is important to note that, as of the time of this writing, ACOG has not updated their guidelines to reflect the information in the interim guidance; therefore, although members of this organization participated in the panel, the information in the interim guidelines has not officially been endorsed by those organizations.

The following is a summary of the guidance (30):

• A negative hrHPV test provides greater reassurance of low CIN3+ risk than a negative cytology result. Therefore, because of equivalent or superior effectiveness, primary hrHPV screening can be considered an alternative to current U.S. cytology-based cervical cancer screening methods. Cytology alone and cotesting remain the screening options specifically recommended in the guidelines.
• Positive hrHPV results call for a combination of genotyping for HPV types 16 and 18 and reflex cytology for individuals positive for the 12 other hrHPV genotypes.
• Rescreening after a negative primary hrHPV screen should occur no sooner than every three years.
• Primary hrHPV screening should not begin before age 25. Although using the hrHPV test for individuals age 25 through 29 may result in increased CIN type 3 detection, the impact of the increased number of colposcopies, integration with screening performed before age 25, and actual impact on cancer prevention needs further investigation.
  

The study also states that, "to achieve the maximum benefit of screening, we need to continue to identify women who are either unscreened or underscreened." (30)

Educate Patients about the Importance of Cervical Cancer Screening

Action Recommendation: Educate patients about the nature of the Pap and HPV tests as screening tools, and provide information about cervical cancer risks and the importance of periodic cervical cancer screening.

Because cervical cancer screening is such an effective tool, it is important to educate adult patients with a cervix on the importance of periodic cervical cancer screening. However, patients should also be informed that the Pap test and the HPV test are not 100% accurate; therefore, a yearly wellness visit should always be scheduled to ensure that the patient is in good health and to detect any warning signs of cervical cancer.

A number of resources are available for patients, including resources from U.S. Centers for Disease Control and Prevention, The American College of Obstetricians and Gynecologists, and The American Cancer Society, that explain how testing is performed, the efficacy of the tests, and why it's important to be screened for cervical cancer.

According to the National Cervical Cancer Coalition, patients should take the following steps to ensure the best and most accurate results from a Pap or HPV test (29):

• The test should be scheduled on a day when the patient is not menstruating. If the patient's period begins unexpectedly and will be continuing on the day of the test, attempts should be made to reschedule the exam for a different day.
• The patient should avoid sexual intercourse in the 48 hours before the test.
• The patient should not douche in the 48 hours before the test.
• The patient should not use tampons or vaginal creams, foams, films, or jellies (such as spermicides or medications inserted into the vagina) for 48 hours before the test.

Engage in Efforts to Increase Access to Cervical Cancer Screening

Action Recommendation: Create opportunities for diagnosis by developing and implementing strategies for primary care providers to identify and offer cervical cancer screening to individuals who have never been screened or whose screening status is uncertain.

The early detection of cervical cancer is critical to successful treatment of the disease. When detected early, the five-year relative survival rate for cervical cancer is 92% at the localized SEER stage, compared to 17% for cancers detected at the distant stage (3). However, access to screening may be limited in certain geographic areas or in certain populations. For example, women who have the fewest years of schooling are the least likely to be screened, and African American and Hispanic women are disproportionately represented among those who develop cervical cancer (35). According to ACS, most cervical cancers are found in women who have never had a Pap test or who have not had one recently (14). Many experts believe that because of this, implementing strategies to increase access to cervical cancer screening—and to guide follow-up evaluation and care—is the most important factor in reducing the rate of cervical cancer in the United States.

Socioeconomic status and financial issues can play an important role in whether women are routinely screened for cervical cancer. Studies have shown that women who are poor or uninsured, have low educational levels and low health literacy, face cultural and language barriers, have fearful misconceptions about cancer, or distrust healthcare providers comprise a population at risk of becoming lost to the system and experience delayed diagnosis of cervical cancer as a result. Additionally, those without insurance are more likely to be diagnosed with late-stage cervical cancer than those who are privately insured. (14) (For more information, see the guidance articles Culturally and Linguistically Competent Care and Health Literacy.) To help alleviate financial issues, programs like the NBCCEDP exist, which can help poor or uninsured women or women in underserved communities receive much needed check-up visits and cervical cancer screening. Providers can do their part to help identify underserved women who may have such financial issues and direct them to programs like the NBCCEDP. (24) For more information, see the section Federal and State Laws.

Various methods can be employed to increase cervical cancer screening rates. These can include sending reminder cards, sending invitation letters to new patients, launching a promotional campaign to promote cervical cancer screening awareness, using telephone campaigns to remind patients to schedule their screenings, providing face-to-face education on the benefits of cervical cancer screening at a patient's appointment, using a clinical decision support system, and providing opportunities for group education. (36)

One study looked at different outreach interventions employed in various developed countries to determine which were most effective at increasing cervical cancer screening rates. The authors found that invitation letters for screening were most effective, and seemed to be more cost-effective than methods such as telephone interviews or promotional campaigns. Face-to-face education and group education were also found to be effective. (36)

Healthcare organizations should also make an effort to promote cervical cancer screening to transgender men, and to improve the patient experience for such individuals by promoting a more sensitive and supportive setting. Such efforts may include using culturally sensitive language, interviewing the patient prior to disrobing, investigating methods to make the pelvic exam less uncomfortable for this population, and asking the patient to change from the waist down only. (18)

The Health Resources and Services Administration (HRSA) has developed an educationmodule on cervical cancer improvement strategies designed to help facilities improve their cervical cancer screening rates. The HRSA module demonstrates two approaches often used by quality improvement teams that are working to improve cervical cancer screening rates: the Care Model approach and the Critical Pathway approach. It also includes case studies for each method and tables highlighting strategies that have been successful in increasing screening rates within each care method. The HRSA module is meant to help facilities guide and organize ideas but also to allow flexibility and creative planning to better suit the facility's needs. (37)

Review Laboratory Policies and Procedures

Action Recommendation: Ensure that cervical cytology laboratory results are clearly and accurately documented and communicated to the referring healthcare provider using a reporting nomenclature such as the Bethesda System.

Action Recommendation: Review laboratory policies and procedures to ensure compliance with CLIA regulations and to ensure that documentation of clinical history is required on requisition forms to identify patients at high risk of cervical cancer.

Action Recommendation: Determine whether appropriate mechanisms are in place to reduce the risk of misidentification of Pap smear slides in the laboratory.

To avoid litigation related to cervical cancer misdiagnosis, it is important to be proactive throughout the screening process, from taking a patient's history to following up in a timely manner with a patient after receiving test results. Several areas were identified by The Doctors Company as common areas where mistakes can be made that can expose the facility to litigation: patient profile, screening recommendations, management of abnormal Pap test/smear, appropriate follow-up, documentation, and communication (5).

Patient profile. To avoid risks, a complete patient history should be taken, and patients at high risk for cervical cancer should be identified and closely followed. Treatment of high-risk patients includes providing adequate HPV and HIV screening, timely Pap smears, yearly pelvic exams, and comprehensive patient education. (5)

In addition, a significant area of liability risk for primary care providers and laboratories concerns the documentation of patient' clinical history on laboratory requisition forms. CLIA specifies that requisition forms for laboratory tests must include the following (38):

• The patient's name or unique identifier
• The sex and age or date of birth of the patient
• The test to be performed
• The source of the specimen, when appropriate
• The date and time of specimen collection
• For Pap smears, the patient's last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy
• Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable
  

Absence of the patient's clinical history may increase the risk of delayed or missed diagnosis if a test result from a patient with a history of abnormal Pap tests, biopsy, or treatment is reviewed only once by a cytologist. However, obtaining a comprehensive patient history may be challenging, as patients may have seen multiple healthcare providers and may have incomplete records. Educating clinical staff and patients on the important role of clinical history in cervical cancer screening may result in improved documentation.

Screening recommendations. The Doctors Company recommends that clinicians adhere to recommended cytology guidelines (for more information, see Cervical Cancer Screening Guidelines), but notes that these recommendations do not preclude the need for comprehensive yearly exams. (5)

Management of abnormal Pap test/smear. Clinicians should follow up with patients who have abnormal screening results. Such patients should be retested with the appropriate testing and follow-up regimen, as indicated by current guidelines. (5)

Appropriate follow-up. According to The Doctors Company, establishing a reliable mechanism for tracking diagnostic testing and test results will significantly reduce exposure to claims asserting delay in diagnosis. Such a mechanism must ensure that all diagnostic studies, consultations, and test results are received and reviewed, and that the results are sent to and reviewed by the physician before they are placed in the patient's chart. (5)

Documentation. The Doctors Company states that, in many scenarios, "an otherwise medically defensible claim is compromised by inadequate documentation." Documentation should seek to "create a chronological word picture of the assessment, diagnosis, treatment plans, and outcomes," and should detail the following (5):

• Instructions to the patient (e.g., follow-up, further testing, referral to specialist) and clinical care decisions
• Any telephone instructions provided
• Signed consent forms that specify the risks, benefits, and alternatives of the diagnostic study or treatment
• Informed consent conversations
• Medical rationale supporting the clinician's assessment, the diagnosis established or pending, and the treatment plan and subsequent alterations in conjunction with the patient's clinical status
• The patient's understanding of the need for subsequent studies
  

When documenting, the clinician should ask the question, "Will I be able to defend my actions retrospectively?"

In addition, risk managers should be aware of a document from theAmerican Society of Cytopathology that discusses guidelines for review of gynecologic cytology samples in the context of investigation, litigation, or potential litigation. The guidelines emphasize that the reporting of a false-negative Pap smear is not necessarily evidence of practice below the accepted standard of care and should be made available to defense attorneys, liability insurers, and healthcare risk managers involved in selecting or retaining experts to review Pap smears. (39)

Communication. It is important that all members of the clinical team and the patient communicate effectively, particularly when conveying a cancer diagnosis. Clinicians should be ready to allow the patient time to process the news while still providing written information about therapeutic options and support resources for the patient. (5)

CLIA Requirements

Risk managers should be aware of the following requirements under CLIA and should review laboratory policies to ensure compliance (38):

• Review by a supervising cytotechnologist (i.e., one with three or more years of experience) of slides randomly selected from the total caseload and of at least 10% of the gynecologic slides interpreted by cytotechnologists as negative for epithelial cell abnormalities and other malignant neoplasms.
• Comparison of available clinical information with cytology reports and comparison of all gynecologic reports with a diagnosis of high-grade squamous intraepithelial lesion (HSIL), adenocarcinoma, or other malignant neoplasms with the histopathology report, if available in the laboratory (on-site or in storage), and a determination of the causes of any discrepancies.
• For each patient with a current HSIL, adenocarcinoma, or other malignant neoplasm, laboratory review of all normal or negative gynecologic specimens received within the previous five years, if available in the laboratory (either on-site or in storage). If significant discrepancies are found that will affect current patient care, the laboratory must notify the patient's physician and issue an amended report.
• Documentation of initial examinations and all rescreening results.
• Annual statistical laboratory evaluation of the number of cytology cases examined; specimens processed (by specimen type); patient cases reported by diagnosis; gynecologic cases with a diagnosis of HSIL, adenocarcinoma, or other malignant neoplasm for which histology results were available for comparison; gynecologic cases in which cytology and histology are discrepant; and gynecologic cases in which any rescreen of a normal or negative specimen results in reclassification as low-grade squamous intraepithelial lesion (LSIL), HSIL, adenocarcinoma, or other malignant neoplasm.
• Evaluation of the case reviews of each individual, examining slides against the laboratory's overall statistical values, documentation of any discrepancies, including reasons for the deviation and, if appropriate, corrective actions taken.
• Setting and reassessing workload limits for each cytotechnologist performing primary screening based on criteria established in the regulation.
• Limiting the number of slides examined by an individual in each 24-hour period to 100 in no less than an eight-hour work day.
• Maintaining records to document the workload limit of each individual and total number of slides examined by each individual during each 24-hour period and the number of hours spent examining slides in the 24-hour period irrespective of the site or the laboratory.
• Confirmation by a supervising pathologist of each gynecologic slide interpreted to show reactive or reparative changes or abnormalities described in the regulation and a report signed to reflect such review. (Electronic signatures must be authorized by the supervising pathologist who performed the review.)
• Identifying and reporting unsatisfactory specimens or slide preparations.
• Use of narrative descriptive nomenclature for all results.
• Indication for the basis for corrected reports.
• Retention of slides for at least 5 years and reports for 10 years.

The Bethesda System

To ensure appropriate clinical management of the patient, the results of Pap tests must be clearly and accurately documented and communicated to the referring healthcare provider. The Bethesda System is the most widely accepted reporting nomenclature for cervical cytology reporting—by early 2003, the terminology was being used by 85.5% of U.S. laboratories (40). It was developed to unify the terminology used for reporting results and thus aid in managing cervical epithelial abnormalities. First proposed in 1988, it has undergone several revisions. Most recently revised in 2014, this terminology includes the following (41):

• Specimen adequacy. Each laboratory must report whether the sample was adequate and if the quality of the smear was satisfactory. Clinicians should check whether the test has been marked "satisfactory" or "unsatisfactory."
• Interpretation/results. This is where most of the important findings are reported. There are four sections: negative for intraepithelial lesion or malignancy, other—endometrial cells present in a woman age 40 or older, epithelial cell abnormalities, and other malignancies.
• Squamous abnormalities. These include atypical squamous cells of unknown significance (ASC-US), cells where HSIL or high-grade changes cannot be excluded (ASC-H), low-grade squamous intraepithelial lesion (LSIL), HSIL, and squamous cell carcinoma.
• Glandular abnormalities. These include atypical cells, not otherwise specified (AGC); atypical cells, favor neoplastic; adenocarcinoma in situ; and adenocarcinoma.
• Other malignancies.
  

The Bethesda System includes more than just terminology to report Pap test results. As an aid to achieving accurate and uniform interpretation of Pap smears, a joint task force of the American Society of Cytopathology and the National Cancer Institute developed a web-based collection of cervical cytology images, complementing its Bethesda System atlas of images, educational materials, references, sample reports, and other items. The web-based collection includes 349 images, including "classic" examples of an entity as well as images that were selected to illustrate interpretive dilemmas or "borderline" cytomorphologic features that may not be interpreted the same way by all pathologists. (42) The collection also includes a self-test to allow users to compare their interpretations of specimens with those of others. According to Nayar and Wilbur, more than 60,000 individuals from all over the world have taken the self-test alone (40).

Avoiding Patient Misidentification

Patient identification errors are common and can pose a significant threat to patient safety—in fact, the topic was the subject of the 2016 Deep Dive by ECRI PSO (now ECRI and the ISMP PSO). Clinically significant misidentification errors can occur at any point of the laboratory testing process. Factors that may contribute to specimen mislabeling in the laboratory can include the following (43):

• Failure to have or to follow protocols
• Labeling of samples by nonlaboratory personnel
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• Centralized label printing
• Poor handling or disposal of labels
  

The Deep Dive recommends the following best practices to reduce the likelihood of patient identification errors; the following can apply to cytology collection (43):

• Use two patient identifiers (e.g., patient name and date of birth) to confirm the person's identity at the beginning of each encounter.
• Avoid "leading" the patient when asking for identifiers—for example, use statements such as, "Please tell me your name and date of birth," instead of, "Are you John Doe?"
• Confirm patient' identity before labeling specimen containers. Staff should not label containers until the specimen has been collected. After double-checking identification information for the patient, attach the label to the container in the patient's presence. It's best to carry multiple preprinted specimen labels for only one patient at a time so the wrong one is not used.

Follow Up with Patients

Action Recommendation: Encourage physicians and other healthcare providers who perform cervical cancer screening to implement a policy and procedure to notify patients about when to have their next screening.

Action Recommendation: Evaluate policies and procedures concerning follow-up after screening tests to ensure that patients receive their results and that patients requiring additional care are not lost to the system.

Because cervical cancer is most treatable when it is caught early, providers must emphasize to patients the importance of scheduling and receiving periodic screening. ACOG states that healthcare providers should encourage patients to complete studies believed essential for patient care, such as Pap tests and mammograms, within an acceptable time frame, and that offices providing such services should establish a simple, reliable tracking and reminder system to facilitate communication, improve patient safety and quality of care, and minimize missed or delayed diagnoses. (44)

In addition, it is important to follow up with patients about their cytology results, and follow-up appointments should be scheduled as necessary. Many facilities are using patient portals to notify patients of test results, although notifying a patient with a letter or phone call is also acceptable, provided that the method adheres to the regulations in the Health Insurance Portability and Accountability Act of 1996 (HIPAA). For information on tracking results from outside laboratories, see the guidance article, Test Tracking and Follow-Up; also, see the video below.

According to ACOG, the following characteristics are important for any reminder system, whether electronic or paper based (44):

• Policies and procedures. The tracking policy and procedure should be developed with input from the staff, and all staff should agree to adhere to the same protocols, including those related to documentation of follow-up, time frames for when to expect and relay test results, and those related to handling delayed or missing reports.
• HIPAA compliance. Whether by mail or electronically, all means of contacting patients should adhere to HIPAA regulations. Care also must be taken to limit the amount of information disclosed by way of voice mail or to other individuals who may answer the call without prior consent. Instead, it may be preferable to leave a name and telephone number, asking the patient to call the office.
• Specificity. The reminder system should contain specific data and dates, including the dates for receipt of information and timelines for notifying the patient.
• Location. The reminder system should be centrally located in the office and should not be kept in individual patient charts. Reminders should be accessible to the entire staff.
• Reliability. Office staff should be cross-trained so that the system is reliable and efficient and does not rely on any one person. It should be updated and monitored regularly.
  

ACOG states that practitioners should remind patients about the importance of keeping any postoperative visits and other follow-up appointments and should document any instances of a missed appointment in the medical record. Providers should also attempt to contact patients who miss appointments to help them reschedule. In addition, The Doctors Company recommends that clinicians consider terminating the physician-patient relationship with nonadherent patients. (5)

Foster Nonpunitive Error Reporting in a Safety Culture

Action Recommendation: Foster the development of a safety culture that embraces nonpunitive reporting for laboratory system problems and errors.

​Risk managers should ensure that staff and employees who identify and report system problems and errors are appropriately acknowledged for their efforts. Reporting such errors should be viewed as more than fulfilling regulatory requirements; it should be seen as necessary for patient safety. The organization should foster a supportive, nonpunitive culture and a true accountability to deliver safe patient care. To embed such a culture requires true leadership commitment to build and maintain the trust of staff. For more information, see Event Reporting.