Transcript Document

SPECIMEN TYPE:

Indicate conventional smear (Pap smear) vs. liquid based vs.
other
SPECIMEN ADEQUACY

Satisfactory for evaluation (describe presence or absence of
endocervical/transformation zone component and any other
quality indicators, e.g., partially obscuring blood, inflammation,
etc.)

Unsatisfactory for evaluation ... (specify reason)
• Specimen rejected/not processed (specify reason)
• Specimen processed and examined, but unsatisfactory for evaluation
of epithelial abnormality because of (specify reason)
GENERAL CATEGORIZATION (optional)

Negative for Intraepithelial Lesion or Malignancy

Epithelial Cell Abnormality: See Interpretation/Result (specify
‘squamous’ or ‘glandular’ as appropriate)

Other: See Interpretation/Result (e.g. endometrial cells in a
woman ³ 40 years of age)
AUTOMATED REVIEW

If case examined by automated device, specify device and result.
ANCILLARY TESTING

Provide a brief description of the test methods and report the
result so that it is easily understood by the clinician.
INTERPRETATION/RESULT

NEGATIVE FOR INTRAEPITHELIAL LESION OR MALIGNANCY
• ORGANISMS:





Trichomonas vaginalis
Fungal organisms morphologically consistent with Candida spp
Shift in flora suggestive of bacterial vaginosis
Bacteria morphologically consistent with Actinomyces spp.
Cellular changes consistent with Herpes simplex virus
• OTHER NON NEOPLASTIC FINDINGS (Optional to report; list not
inclusive):

Reactive cellular changes associated with
• inflammation (includes typical repair)
• radiation
• intrauterine contraceptive device (IUD)



Glandular cells status post hysterectomy
Atrophy
OTHER

Endometrial cells (in a woman ³ 40 years of age)
EPITHELIAL CELL ABNORMALITIES

SQUAMOUS CELL

Atypical squamous cells
• of undetermined significance (ASC-US)
• cannot exclude HSIL (ASC-H)


Low grade squamous intraepithelial lesion (LSIL)
encompassing: HPV/mild dysplasia/CIN 1
High grade squamous intraepithelial lesion (HSIL)
encompassing: moderate and severe dysplasia, CIS/CIN 2 and CIN 3
• with features suspicious for invasion (if invasion is suspected)


Squamous cell carcinoma
GLANDULAR CELL

Atypical
• endocervical cells (NOS or specify in comments)
• endometrial cells (NOS or specify in comments)
• glandular cells (NOS or specify in comments)

Atypical
• endocervical cells, favor neoplastic
• glandular cells, favor neoplastic


Endocervical adenocarcinoma in situ
Adenocarcinoma
•
•
•
•


endocervical
endometrial
extrauterine
not otherwise specified (NOS)
OTHER MALIGNANT NEOPLASMS: (specify)
EDUCATIONAL NOTES AND SUGGESTIONS (optional)
Specimen Adequacy

1991 Bethesda System: Adequacy of the Specimen
•
Satisfactory for evaluation
•
Satisfactory for evaluation but limited by…
•
Unsatisfactory for evaluation
The unsatisfactory category should be maintained because it emphasizes
specimen unreliability for evaluation of epithelial lesions.
Unsatisfactory Specimen Reporting
The “Unsatisfactory” category currently includes both specimens that are
rejected and specimens that are fully evaluated.
Recommendation:
Suggested wording to clarify reports follows:

Rejected Pap:
• Specimen rejected (not processed) because ____(specimen not
labeled, slide broken, etc.)

Fully evaluated unsatisfactory Pap :
• Specimen processed and examined, but unsatisfactory for evaluation
of epithelial abnormality because of ____(obscuring blood, etc.)
• Additional comments/recommendations, as appropriate
Conventional Smear Squamous Cellularity
“Well-preserved and well-visualized squamous epithelial cells
should cover more than 10% of the slide surface.”
Recommendation:

Change the criterion to “An adequate conventional
specimen has an estimated minimum of approximately
8,000-12,000 well-preserved and well-visualized squamous
epithelial cells.”

Note: THIS MINIMUM CELL RANGE SHOULD BE ESTIMATED,
AND LABORATORIES SHOULD NOT COUNT INDIVIDUAL
CELLS IN CONVENTIONAL SMEARS.

Provide “reference images” of known cellularity.
Endocervical/Transformation zone component
“at a minimum, of two clusters of well-preserved endocervical glandular
and/or squamous metaplastic cells, with each cluster composed of at least
five cells.”
Recommendation:
•
•
•
At least 10 well-preserved endocervical or squamous metaplastic cells should be
observed to report that a transformation zone component is present.
The presence or absence of a transformation zone component should be reported
in the specimen adequacy section, but absence does not mean a patient requires
early repeat.
Parabasal type cells should not be used as an indication of transformation zone
sampling.
Obscuring factors
•
Current Bethesda criteria are 50-75% of cells obscured for SBLB specimens, and
>75% of cells obscured for unsatisfactory specimens
Recommendations:
•
No change in criteria is proposed. Specimens with >75% of cells obscured
should be termed unsatisfactory (assuming no abnormal cells are present).
When 50-75% of cells are obscured, a statement describing the specimen as
partially obscured should follow the satisfactory term.
Recommendations and
Educational Notes
The Cytology Report is a Medical Consultation
1.
2.
3.
4.
The cytopathologist has ultimate responsibility for the
evaluation and report.
The referring physician has an obligation to include all
pertinent clinical information in the request for cytopathologic
evaluation so that the cytopathologist can consult effectively.
The cytopathologist should determine whether the specimen
is adequate for evaluation. If it is unsatisfactory or less than
optimal, this should be noted on the report
The report should include a recommendation for further
patient evaluation when appropriate.
one of the areas examined by a 2001Bethesda System Working
Committee has been the potential use of recommendations and
educational notes, including disclaimer-like notes in the
cervicovaginal cytology report.
Recommendation:
The use of recommendations is therefore considered
appropriate under the following circumstances:
1.
When further procedures would be helpful to
clarify ambiguous morphologic findings.
2. To improve the quality of a repeat specimen
following one of limited adequacy.
3. To identify patients with certain interpretations that
require further triage and potential subsequent
management.
Additional Uses of Educational Notes
Recommendations:
Educational notes are optional. If used, they should be
carefully worded, concise, clear and evidence-based.
Examples of interpretive results with notes and
recommendations:


Interpretation: Atypical Glandular Cells
Recommendation: As a significant percentage of patients
with this interpretation have underlying high-grade
squamous or glandular intraepithelial abnormalities, further
diagnostic patient follow-up procedures are suggested as
clinically indicated.
--------------------------


Interpretation: Unsatisfactory due to lack of cellular
material and air-drying artifact (in a post-menopausal
woman).
Recommendation: A short course of estrogen cream is
suggested before obtaining a repeat specimen in order to
induce maturation of the squamous epithelium.
Ancillary Testing
Recommendations
1991 Bethesda Terminology
None reported for Ancillary Testing

Recommendation:
• For all laboratory based ancillary tests, a brief description of
the methods should be provided, and the results should be
reported in a manner conducive to clinician understanding.
• For HPV testing, the results should be reported as positive or
negative for HPV DNA of a certain type or class and the
laboratory method should be indicated.
• HPV testing has been shown to lack utility for triage of women
who have LSIL or HSIL diagnoses.
• Thus, given the current data, clinical recommendations
associated with HPV testing should be limited to women who
have an ASCUS diagnosis.
Benign Cellular Changes:
Recommendations after the
Bethesda Conference
Benign Cellular Changes and Infections
GENERAL CATEGORIZATION


What terminology should be used for negative
and reactive specimens in the General
Categorization?
"Negative for intraepithelial lesion or
malignancy" is preferred in the report so that
organisms and other benign cellular changes may be
included under this general category.
RECOMMENDATION AFTER THE BETHESDA CONFERENCE
GENERAL CATEGORIZATION (Optional)
• Negative for intraepithelial lesion or malignancy (includes
organisms and reactive cellular changes)
• Epithelial cell abnormality: (Specify squamous or glandular as
appropriate) (See interpretation/diagnosis)
• Other: (See interpretation/diagnosis) (includes conditions that
do not fit under the first two categories such as exfoliated
endometrial cells in a woman over 40 years of age and nonepithelial malignancies)
For Interpretations/Diagnoses include in Bethesda
2001 the following:
• Reactive cellular changes associated with:



Inflammation (includes typical repair)
Radiation
Intrauterine contraceptive device (IUD)
• Other Findings
Where should infections be listed within the terminology and in the
report?
RECOMMENDATION :

The consensus of opinion at the conference was to change the
"infections" category to "organisms".

Modification of the infection list
RECOMMENDATION :
•
Organisms






Trichomonas Vaginalis
Fungal organisms morphologically consistent with Candida spp
Shift in vaginal flora suggestive of bacterial vaginosis
Bacteria morphologically consistent with Actinomyces spp
Cellular changes associated with Herpes simplex virus
Other
Chlamydia should not be listed as an infectious entity in the Bethesda System
to be diagnosed routinely on Pap smear. (No change)
Change the term "Predominance of coccobacilli consistent with shift in vaginal
flora" to "Shift in vaginal flora suggestive of bacterial vaginosis" The
clinician can then use clinical judgment to determine if additional tests or
treatment is indicated.
Recommendations of the ASCUS



Replace ASCUS with a new category “Atypical
Squamous Cells (ASC)”
Eliminate the qualifier, “Favor Reactive” for
equivocal cytology. Recommend that
pathologists judiciously downgrade many
cases formerly classified as “ASCUS, Favor
Reactive.”
Qualify Atypical Squamous Cells (ASC) as
“Undetermined Significance (ASC-US)” or
“Cannot Exclude HSIL (ASC-H)”



Atypical Squamous Cells of Undetermined
Significance (ASC-US): cytologic changes that are
suggestive of a squamous intraepithelial lesion,
but lack criteria for a definitive interpretation.
The category includes: 1) a minority of cases
formally classified as ASCUS, Favor Reactive and
2) most cases formally classified as ASCUS, NOS
or ASCUS, Favor SIL.
Atypical Squamous Cells; Cannot Exclude HSIL
(ASC-H): cytologic changes that are suggestive
of HSIL, but lack criteria for definitive
interpretation.
ASC reports should not exceed 5% of total
specimens with ASC:SIL ratios not higher than
2:1 to 3:1 in general screening populations.
LSIL / HSIL Forum Draft
1991 Bethesda System

Squamous Intraepithelial Lesion (SIL)
•
•
Low-grade squamous intraepithelial lesion (LSIL)
High-grade squamous intraepithelial lesion (HSIL)
2001 Recommendations
Terminology used for squamous intraepithelial lesions.

Recommendation: LSIL and HSIL should continue to be
included as two separate categories under Epithelial Cell
Abnormalities - Squamous Cell. Moreover, the dividing line
between LSIL and HSIL should be between CIN 1 (mild
dysplasia) and CIN 2 (moderate dysplasia).
Retention of cellular changes associated with HPV cytopathic
effect (so-called koilocytotic atypia) in the LSIL category.

Recommendation: No modification should be made to TBS in
this regard and cervical cytology specimens with the cellular
features associated with HPV cytopathic effect (e.g., koilocytosis)
should continue to be included under Epithelial Cell Abnormalities
- Squamous Cell – Low-grade squamous intraepithelial lesion
(LSIL).
Classification of gynecological cytology samples showing HSIL
in which invasion cannot be ruled-out.

Recommendation: Gynecological cytology cases showing
diagnostic HSIL in which there is non-diagnostic cytological
evidence of invasion should be diagnosed as HSIL and
accompanied by the comment “with features suspicious for
invasion”.
Proposed 2001 Bethesda System

Squamous Intraepithelial Lesion (SIL)
•
•
Low-grade squamous intraepithelial lesion (LSIL)
High-grade squamous intraepithelial lesion (HSIL)
Atypical Glandular Cells –Recommendations
revised post-meeting
AIS as a discrete entity; Atypical Glandular Cell Qualifiers
Recommendations:

“Endocervical adenocarcinoma in situ” should be added as a discrete
interpretation/diagnosis when criteria are adequate for this interpretation.
In cases showing near complete features (criteria) of AIS, an intermediate
category of “Atypical endocervical cells, probably AIS” is appropriate

The category “Atypical glandular/endocervical/endometrial cells” should be
retained, however,
The qualifier “of undetermined significance” (AGUS) should be eliminated to
avoid confusion with ASCUS.
In addition, the qualifier “favor reactive” should be eliminated. The qualifier
“favor neoplastic” should be retained;
Categories under the “atypical glandular” heading:
•
•
Atypical Glandular/Endocervical/Endometrial Cells (unqualified)
Atypical Glandular/Endocervical Cells, Favor Neoplastic

specify further in description
The Presence of Benign Glandular Cells in the
Specimens from Post-Hysterectomy Women
Data from the literature show that no patient
having benign glandular cells in vaginal smears
post-hysterectomy developed recurrent or de
novo neoplastic lesions regardless of the history
of prior malignancy.
Recommendations:
• “Low grade glandular intraepithelial lesion” and/or
“endocervical glandular dysplasia” should not be utilized.
• Proposed criteria for AIS and Atypical Glandular Cells
were presented at the meeting.
Bethesda 2001 Endometrial Forum
Group Workshop Summary
An introductory comment for TBS 2001 was
formulated: “Cervical/vaginal cytology is a
screening tool for squamous cell carcinoma and
its precursor lesions. It is an inaccurate test for
detection of endometrial lesions and should not
be used to evaluate causes of suspected
endometrial abnormalities.”
Recommendation:
• Because of the lack of clinical impact and the unreliable
clinical data often supplied with the sample, endometrial
cells need not be reported in women less than 40 years.
Reporting benign appearing exfoliated endometrial
cells in a woman over 40 years of age

General Categorization:
• Other

Descriptive Interpretation:
• “Endometrial cells present. -See Comment. “
• “No evidence of squamous intraepithelial lesion.”(Optional)

Educational note:
• “Endometrial cells after age 40, particularly out of phase or
after menopause, may be associated with benign
endometrium, hormonal alterations and less commonly,
endometrial/ uterine abnormalities. Clinical correlation is
recommended.”
Hormonal Evaluation
• Recommendation:

Delete this category in the Bethesda System.