Feature Story

How Pap adequacy affects patient management

January 2003
Diane D. Davey, MD

Bethesda 2001 made significant changes in adequacy terminology, including eliminating the “satisfactory but limited by” category.¹ This category was considered confusing—was the specimen satisfactory or not? There was considerable variation in patient followup, including unnecessary early repeat Pap tests. Many participants felt that adequacy guidelines for patient followup would be helpful in light of the revised terminology.

The American Society for Colposcopy and Cervical Pathology appointed a task force to address adequacy issues after the 2001 consensus guidelines conference for managing abnormal Pap tests. This task force included Bethesda 2001 Adequacy Forum moderators and additional clinician members. The recently compiled adequacy management guidelines were published first in the Journal of Lower Genital Tract Disease² and subsequently published in other medical journals. The guidelines address three questions:

1. If a Pap report is negative for intraepithelial lesion or malignancy but lacks an endocervical/transformation zone component, what action should the physician take?
2. What followup should occur for a woman whose negative Pap test has partially obscuring blood, inflammation, or other factors, or partial air? drying?
3. What action should be taken if a Pap report shows an unsatisfactory result?

For the first two situations, the recommended actions are similar. Most women undergoing routine screening (at least biennially) should be scheduled for a repeat Pap test in 12 months. Pregnant patients should be scheduled for postpartum repeat. An early repeat (at about six months) may be helpful for some women, as indicated below.

Pap with no endocervical component or partially obscuring factors: suggested followup

• Schedule most patients for a repeat Pap test in 12 months (assuming patient participation in regular screening).
• Schedule postpartum repeat for pregnant patients.
• A six-month repeat may be helpful in the following circumstances: previous squamous abnormality (ASC-US or worse) without three subsequent negative Paps; previous Pap with unexplained glandular abnormality; positive high-risk HPV test within 12 months; inability to clearly visualize the cervix or sample the endocervical canal; immunosuppression (HIV+); similar obscuring factor in consecutive Pap tests; insufficient previous (at least biennial) screening.

Unsatisfactory Paps

A repeat Pap test within two to four months is the preferred followup in most situations. If the unsatisfactory result is due to obscuring inflammation and an organism is identified, specific treatment can be given before repeating the Pap. If the Pap test is repeatedly unsatisfactory due to obscuring blood, inflammation, or necrosis, additional clinical evaluation, such as colposcopy or biopsy, may be helpful. An unsatisfactory Pap test is considered unreliable for evaluating epithelial abnormalities. A longitudinal study done at the University of Kentucky³ found that unsatisfactory Paps were more likely to come from high-risk patients, and significantly more patients with unsatisfactory Paps were found on followup to have squamous intraepithelial lesion cells or cancer than were patients with satisfactory index Paps.

Significance of endocervical component and quality indicators

The ASCCP Pap adequacy guidelines review this topic extensively. Several cross-sectional studies have found that squamous intraepithelial lesion cells are more common in Paps in which endocervical/transformation zone, or EC/TZ, cells are present, but other studies have found no differences. Multiple retrospective longitudinal cohort studies have shown that patients with Paps lacking EC/TZ cells are not more likely to have squamous lesions upon followup than are patients with EC/TZ cells. Finally, retrospective case?control studies have failed to correlate false-negative Pap reports and lack of EC/TZ cells or partially obscuring factors. The annual followup ASCCP suggests is a reasonable compromise in light of the conflicting data on EC/TZ cells. Given the increasing incidence of adenocarcinoma cases, annual repeats promote patient safety when no EC/TZ elements are present. A repeat in two years instead of one may be considered if the patient has been screened regularly for several years without abnormalities. A recent negative high-risk HPV test also suggests a low risk for cervical pathology and supports a regular screening interval.

References

1. Solomon D, Davey D, Kurman R, et al. The 2001 Bethesda system: terminology for reporting results of cervical cytology. JAMA. 2002;287:2114–2119.
2. Davey DD, Austin RM, Birdsong G, et al. ASCCP patient management guidelines: Pap test specimen adequacy and quality indicators. J Lower Gen Tract Dis. 2002;6:195–199. Also published in Am J Clin Pathol. 2002;118:714–718.
3. Ransdell JS, Davey DD, Zaleski S. Clinicopathologic correlation of the unsatisfactory Papanicolaou smear. Cancer Cytopathol. 1997;81:139–143.

Dr. Davey is past chair of, and former advisor to, the CAP Cytopathology Committee and professor of pathology and laboratory medicine and laboratory director of the cytopathology and bone marrow laboratories at the University of Kentucky Chandler Medical Center, Lexington.