How Pap adequacy affects patient management
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:
- If a Pap report is negative for intraepithelial lesion or malignancy
but lacks an endocervical/transformation zone component, what
action should the physician take?
- What followup should occur for a woman whose negative Pap test
has partially obscuring blood, inflammation, or other factors,
or partial air? drying?
- What action should be taken if a Pap report shows an unsatisfactory
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:
- 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.
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
- Solomon D, Davey D, Kurman R, et al. The 2001
Bethesda system: terminology for reporting results of cervical
cytology. JAMA. 2002;287:2114–2119.
- 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.
- Ransdell JS, Davey DD, Zaleski S. Clinicopathologic
correlation of the unsatisfactory Papanicolaou smear. Cancer
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.