The Bethesda System for Reporting Cervical Cytology


The Bethesda System: Historical Perspective

Terminology forms the basis for effective communication between the laboratory and clinician. The clinician is expected to provide relevant patient information to the laboratory. It is the laboratory's responsibility to report results using terminology that clearly conveys the diagnostic interpretation of the morphologic findings. The use of a uniform diagnostic terminology facilitates communication by establishing a common language that, in theory, does not vary significantly from cytologist to cytologist or laboratory to laboratory. However, terminology is not static over time; rather, it evolves in parallel with increased understanding of the pathogenesis and biology of disease. The framework, therefore, must be flexible enough to incorporate advances in scientific knowledge without creating undue confusion or complexity.

In 1988, the National Cancer Institute (NCI) sponsored an open workshop – including cytotechnologists, pathologists, clinicians, and representatives of professional organizations – to develop a uniform descriptive terminology for cervical/vaginal cytologic interpretation. The format that emerged became known as The Bethesda System (TBS).

Approximately 2 years later, a second meeting was convened to critique and refine the terminology based on experience with the use of the system in actual laboratory practice. Minor modifications were incorporated into the 1991 Bethesda System that streamlined the terminology. In addition, an ad hoc committee developed criteria for specimen adequacy and Bethesda interpretive categories, culminating in the first TBS atlas that outlined and illustrated the morphologic features. By the mid- to late 1990s, there was a significant penetration of TBS into cytopathology practice with approximately 90% of laboratories in the USA using the Bethesda terminology for reporting of cervical/vaginal cytology. Articles published since the release of the second manual have shown increased consistency of terminology across countries, which, has greatly facilitated communication between systems which until this time, had little hope of sharing gynecologic screening data.

The fundamental aim of TBS has been to communicate clinically relevant information 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 neoplasia. 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 automated 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 8 months prior to the workshop, nine forum groups, consisting of 6–10 individuals with a breadth of expertise in the area of cervical cancer, were organized under the sponsorship of the NCI to formulate draft recommendations. Internet bulletin boards were open to the worldwide cytology community for 6 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, cytotechnologists, 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.

Following the Bethesda workshop, the American Society for Colposcopy and Cervical Pathology (ASCCP) held a comparable 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. The ASCCP management guidelines were subsequently updated at consensus conferences held in 2006, 2009, and 2012. After the initial publication of TBS 2001 terminology ( Box 6-1 ), the NCI approached the American Society of Cytopathology (ASC) to collaborate on publication of the second edition of the Bethesda Atlas and the development of an accompanying Bethesda System educational website. Images chosen for the atlas and website underwent an extensive selection/validation process, and included classic as well as morphologically difficult and “borderline” images, illustrated on both conventional preparations and liquid-based preparations (LBPs). A subset of images chosen for the Bethesda Atlas were used to assess interobserver reproducibility in gynecologic cytology – the details of this Bethesda interobserver reproducibility project are described below.

Box 6-1
The 2001 Bethesda System

Specimen Type

Indicate conventional smear vs. liquid-based preparation vs. other

Adequacy of the Specimen

  • Satisfactory for evaluation (describe presence or absence of endocervical/transformation zone component and any other quality indicators, e.g., partially obscuring blood, inflammation)

  • 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

  • Other

  • Epithelial cell abnormality: see Interpretation/Result (specify squamous or glandular as appropriate)

Interpretation/Result

Negative for Intraepithelial Lesion or Malignancy

(when there is no cellular evidence of neoplasia, state this in the General Categorization above and/or in the Interpretation/Result section of the report – whether or not there are organisms or other non-neoplastic findings)

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 associated 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 >40 years of age) (specify if “negative for squamous intraepithelial lesion”)

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

  • 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 adenocarcinoma

    • not otherwise specified (NOS)

  • Other Malignant Neoplasms (Specify)

Ancillary Testing

Provide a brief description of the test method(s) and report result so that it is easily understood by the clinician.

Automated Review

If case is examined by automated device, specify device and result.

Educational Notes and Suggestions (Optional)

Suggestions should be concise and consistent with follow-up guidelines published by professional organizations (references to relevant publications may be included).

Planning for a third edition of the Bethesda Atlas is currently underway. This work will focus on the increasing knowledge and experience obtained in the last decade regarding HPV biology and the operating characteristics of liquid-based cytology. In addition, the many management changes made based on long-term follow-up data from TBS categories will form a new section in the monograph. No substantive changes in the terminology are planned, however subtle refinements in several categories will be forthcoming.

Report Format

The basic structure of TBS includes three elements, based on communication needs germane, but not limited, to gynecologic cytology: (1) statement of specimen adequacy, (2) general categorization, and (3) descriptive terminology. The specimen type – conventional smear, LBP, or other – should also be stated in the report ( Box 6-1 ).

Specimen Adequacy

Reporting of adequacy was an important quality assurance measure introduced by TBS. The 1988 Bethesda System incorporated a classification of three categories 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 adequacy. Participants at the 1991 Second Workshop, and others in the cytopathology community, voiced the need for developing consensus guidelines. In response, following the second workshop, a Criteria Committee formulated the definitions 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 cellularity, 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 standardized approach to the evaluation of adequacy. It was emphasized that the indicated percentages should be used as general ranges, not strict numerical cut-offs 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 component of TBS. The previously used borderline adequacy category of “less than optimal” (1988)/“satisfactory but limited by …” (1991) was deleted in order to provide the clinician a clearer and more reproducible indication of the adequacy of the specimen. The classification recommended in TBS 2001 is either as “satisfactory” or “unsatisfactory”:

  • Satisfactory – 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.

  • Unsatisfactory – 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 labelled, broken slide, etc.)

    • Fully evaluated, unsatisfactory specimen – specimen 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 or malignancy, the presence of endometrial cells in a women 40 years or older, or the presence of organisms, can be reported in this context, since this information may prove to be clinically relevant for patient management.

As in prior Bethesda adequacy guidelines, if abnormal cells are detected, the specimen cannot be categorized as “unsatisfactory.”

Squamous Cellularity

TBS 1991 required that well-preserved and well-visualized squamous epithelial cells should cover more than 10% of the slide surface. In order to address adequacy on conventional as well as LBPs, and to improve interobserver reproducibility, TBS 2001 went further to provide numerical estimates of what constitutes adequacy for squamous cellularity in cervical cytology preparations.

  • Conventional smears . An adequate conventional preparation should have a minimum of approximately 8000–12 000 well-preserved and well-visualized squamous cells. This minimum cell count should be estimated , not counted. The count includes both nucleated mature and metaplastic squamous cells. The percentage of hypocellular areas, if present, should be estimated and the fields counted should reflect this proportion. The Bethesda Atlas and website provide “reference images” of known cellularity at low (×4) magnification as a resource for cytologists to compare with the specimen being assessed.

  • Liquid-based preparations . An adequate LBP should have an estimated minimum of at least 5000 well-visualized, well-preserved squamous cells. Estimation of cellularity is suggested in borderline cases by performing representative field counts. A minimum of 10 fields (usually at ×40) are assessed along a diameter that includes the center of the preparation. The average number of squamous cells per field is thus estimated. One preliminary study suggested that LBPs containing 5000–20 000 squamous cells should be considered as “borderline” cellularity.

The reader is referred to the Bethesda Atlas for cellularity tables and figures. TBS numeric criteria for cellularity may not be applicable to vaginal specimens, cases with extensive cytolysis, cell clustering, and some cases of atrophy. Cytologists should utilize clinical information and their best judgment when interpreting such cases. At present, there are no published studies specifically addressing the relationship between low cellularity and false-negative rate.

You're Reading a Preview

Become a Clinical Tree membership for Full access and enjoy Unlimited articles

Become membership

If you are a member. Log in here