PART TWO
Diagnostic Cytology
from the laboratory to the patient's healthcare provider, using
uniform, reasonably reproducible terminology which reflects
the most current understanding of the biology of cervical neo-
plasia. Advances in the understanding of the biology of cervical
cancer, results from clinical trials, the introduction of liquid-
based cytology, human papillomavirus (HPV) testing, and auto-
mated screening devices for cervical cytology led to the decision
to convene the third Bethesda workshop in April 2001.
The 2001 Bethesda System
TBS 2001 Process
Approximately eight months prior to the workshop, nine
forum groups consisting of 6 to
10 individuals with a
breadth of expertise in the area of cervical cancer, were organ-
ized under the sponsorship of the NCI to formulate draft
recommendations. Internet bulletin boards were open to the
worldwide cytology community for six months during the
pre-conference process of review and discussion. Over 1000
comments were considered in revising the pre-workshop
drafts. The 2001 Bethesda workshop was co-sponsored by
44 international professional organizations and attended by
over 400 individuals, including pathologists, cytotechnolo-
gists, gynecologists, attorneys, patient advocates, and other
healthcare workers involved in women's health initiatives.
The revised draft recommendations were presented by each
forum group and after open discussions and voting by all
participants, the 2001 Bethesda consensus terminology was
finalized and published in 2002.7
Following the Bethesda workshop, the American Society for
Colposcopy and Cervical Pathology (ASCCP) held a compara-
ble consensus workshop on patient management in September
2001. This was also preceded by an Internet discussion, and
resulted in the development of evidence-based management
guidelines for abnormal cervical cytology corresponding to
the 2001 Bethesda reporting format.8 The ASCCP management
guidelines were subsequently updated at a consensus confer-
ence held in September 2006.9
After the initial publication of the Bethesda System 2001 ter-
minology (Table 6.1), the NCI approached the American Society
of Cytopathology (ASC) to collaborate on publication of the
second edition of the Bethesda Atlas10 and the development
of an accompanying Bethesda System educational website.11
Images chosen for the atlas and website underwent an exten-
sive selection/validation process, and included classic as well as
morphologically difficult and "borderline" images, illustrated
on both conventional and liquid-based preparations. A subset
of images chosen for the Bethesda atlas were used to assess inter-
observer reproducibility in gynecologic cytology—the details of
this Bethesda interobserver reproducibility project are described
below.12
Report Format
The basic structure of TBS includes three elements, based on
communication needs germane, but not limited, to gyneco-
logic cytology: (1) statement of specimen adequacy, (2) general
categorization, and (3) descriptive terminology. The specimen
type—conventional smear, liquid-based preparation, or other—
should also be stated in the report (Table 6.1).
Specimen Adequacy
Reporting of adequacy was
an
important quality assur-
ance measure introduced by the Bethesda System. The 1988
Bethesda System incorporated a classification of three catego-
ries of specimen adequacy—satisfactory, less than optimal,
and unsatisfactory—into the format of the report but did not
outline specific morphologic criteria for evaluation of ade-
quacy. Participants at the 1991 Second Workshop, and oth-
ers in the cytopathology community,13,14 voiced the need for
developing consensus guidelines. In response, following the
second workshop, a Criteria Committee formulated the defi-
nitions for adequacy based on a combination of experience
and review of an admittedly sparse scientific database. Three
categories—"satisfactory," "satisfactory but limited by.
..," and
"unsatisfactory"—based on estimates of overall squamous cel-
lularity, assessment of the transformation zone component,
and the presence/extent of obscuring or limiting factors, were
suggested in an initial attempt to develop a more standard-
ized approach to the evaluation of adequacy.15 It was empha-
sized that the indicated percentages should be used as general
ranges, not strict numerical cutoffs and that patient-related
clinical factors and previous cytologic findings should always
be taken into consideration.
Bethesda 2001 Specimen Adequacy Categories
In 2001, substantial changes were made to the adequacy compo-
nent of TBS. The previously used borderline adequacy category
of "less than optimal" (1988)/"satisfactory but limited b y ."
(1991) was deleted in order to provide the clinician a clearer
and more reproducible indication of the adequacy of the speci-
men.16 The classification recommended in TBS 2001 is either as
"satisfactory" or "unsatisfactory":
• Satisfactory10—Satisfactory for evaluation (describe
presence or absence of endocervical/transformation
zone component and any other quality indicators,
e.g., partially obscuring blood, inflammation, etc.).
For "satisfactory" specimens, including information
on transformation zone sampling and other adequacy
qualifiers (obscuring elements, poor preservation, etc.)
encourages specimen takers to pay greater
attention to specimen procurement and handling.
Any factors that compromise specimen quality can be
mentioned in a note.
• Unsatisfactory10—For unsatisfactory specimens the
report should indicate whether the laboratory
processed/evaluated the slide. Suggested wording is:
- Rejected specimen—Specimen rejected/not
processed because
(specify reason: specimen not
labeled, broken slide, etc.
).
- Fully evaluated, unsatisfactory specimen—Speci-
men processed and examined, but unsatisfactory
for evaluation of epithelial abnormality because
of
(specify reason: inadequate squamous component,
obscuring blood, etc.
).
Additional comments/recommendations may be made as
deemed appropriate.
While unsatisfactory specimens which are processed and
evaluated are not suitable for excluding an intraepithelial lesion
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