The 2001 Bethesda System: Terminology for …

1 Current as of February 17, 2009. Online article and related content . 2002;287(16):2114-2119 ( ) JAMA Diane Solomon; Diane Davey; Robert Kurman; et al. results of Cervical CytologyThe 2001 Bethesda system : Terminology for reporting Correction Contact me if this article is corrected. Citations Contact me when this article is cited. This article has been cited 529 times. the same issueRelated Articles published in . 2002;287(16) 24, 2002 . 2002;287(16) H. Stoler. Cervical Cytology FindingsNew Bethesda Terminology and Evidence-Based Management Guidelines for . 2002;287(16) C. Wright, Jr et al. Cytological Abnormalities2001 Consensus Guidelines for the Management of Women With Cervical Alerts at HSE: Health Service Executive (Ireland) on February 17, 2009 from CONSENSUS STATEMENTThe 2001 Bethesda SystemTerminology for reporting results of Cervical CytologyDiane Solomon, MDDiane Davey, MDRobert Kurman, MDAnn Moriarty, MDDennis O Connor, MDMarianne Prey, MDStephen Raab, MDMark Sherman, MDDavid Wilbur, MDThomas Wright, Jr, MDNancy Young, MDfor the Forum Group Members andthe Bethesda 2001 WorkshopBACKGROUNDThe Bethesda system for reporting theresults of cervical cytology was devel-oped as a uniform system of terminol-ogy that would provide clear guidancefor clinical firstworkshop was held in 1988.

2 To reducewidespread confusion among labora-tories and clinicians created by the useof multiple classification systems andinconsistently defined numerical grad-ing most important contribution ofthe Bethesda system was the creation ofa standardized framework for labora-tory reports that included a descriptivediagnosis and an evaluation of speci-men adequacy. While not everyoneagreed with every detail of that initial ef-fort, the recommendations of the 1988workshop received widespread accep-tance in second workshopwas held in 1991 to modify the BethesdaSystem based on actual laboratory andclinical experience after its , more than 90% of USlaboratories use some form of the 1991 Bethesda system in reporting cervical the increased utilizationof new technologies and recent find-ings from research studies, 2001 wasconsidered an opportune time to re-evaluate the Bethesda 2001 ProcessEight months prior to the Bethesda2001 Workshop, 9 forum groups (listedAuthor Affiliations:Division of Cancer Prevention, Na-tional Cancer Institute, Bethesda , Md (Dr Solomon); De-partment of Pathology and Laboratory Medicine, Uni-versity of Kentucky Medical Center, Lexington (DrDavey).)

3 Departments of Gynecology and Obstetrics andPathology, Johns Hopkins Hospital, Baltimore, Md (DrKurman); AmeriPath Indiana, Indianapolis (Dr Mori-arty); Clinical Pathology Associates, Louisville, Ky (DrO Connor); Quest Diagnostics Incorporated, St Louis,Mo (Dr Prey); Department of Pathology, Allegheny Hos-pital, Pittsburgh, Pa (Dr Raab); Division of Cancer Epi-demiology and Genetics, National Cancer Institute, Bethesda , Md (Dr Sherman); Department of Pathol-ogy, Massachusetts General Hospital, Boston (Dr Wilbur);Department of Pathology, Columbia University, NewYork, NY (Dr Wright); and Department of Pathology,Fox Chase Cancer Center, Philadelphia, Pa (Dr Young).Financial Disclosure:Dr Wright was the principal in-vestigator of the clinical trials investigating HPV DNAtesting and liquid-based cytology funded by DigeneCorp and Cytyc Corp via formal grants to ColumbiaUniversity.

4 Dr Wright has no financial or equity inter-est in, ongoing consultancy with, or membership onthe scientific advisory board of Digene Corp, whichmakes the only FDA-approved HPV DNA test in theUnited States. Dr Wright currently serves on the speak-er s bureau of Cytyc Corp and Tripath Inc, which makeliquid-based cytology test Group Membersare listed at the end of Author and Reprints:DianeSolomon, MD, EPN Room 2130, 6130 ExecutiveBlvd, Bethesda , MD 20892 (e-mail: Bethesda 2001 Workshop was convened to evaluate and updatethe 1991 Bethesda system Terminology for reporting the results of cervical primary objective was to develop a new approach to broaden participation in theconsensus groups composed of 6 to 10 individuals were responsible fordeveloping recommendations for discussion at the workshop. Each forum group in-cluded at least 1 cytopathologist, cytotechnologist, clinician, and international repre-sentative to ensure a broad range of views and interests.)

5 More than 400 cytopatholo-gists, cytotechnologists, histopathologists, family practitioners, gynecologists, publichealth physicians, epidemiologists, patient advocates, and attorneys participated in theworkshop, which was convened by the National Cancer Institute and cosponsored by44 professional societies. More than 20 countries were review, expert opinion, and input from an Internet bulletin boardwere all considered in developing recommendations. The strength of evidence of thescientific data was considered of paramount ProcessBethesda 2001 was a year-long iterative review process. AnInternet bulletin board was used for discussion of issues and drafts of recommenda-tions. More than 1000 comments were posted to the bulletin board over the courseof 6 months. The Bethesda Workshop, held April 30-May 2, 2001, was open to thepublic. Postworkshop recommendations were posted on the bulletin board for a lastround of critical review prior to finalizing the 2001 was developed with broad participation in the consen-sus process.

6 The 2001 Bethesda system Terminology reflects important advances inbiological understanding of cervical neoplasia and cervical screening 2002;287 also pp 2120 and ,April 24, 2002 Vol 287, No. 16(Reprinted) 2002 American Medical Association. All rights reserved. at HSE: Health Service Executive (Ireland) on February 17, 2009 from at the end of the article) were estab-lished to draft recommendations formodifying the Bethesda system . Aprimary objective was to broadenparticipation by using the Internetin the premeeting development pro-cess. A dedicated Web site ( ) with an elec-tronic bulletin board was established toseek input and critiques of draft rec-ommendations. In total, more than1000 individual comments were postedto the bulletin workshop was held April 30-May 2, 2001, with more than 400 par-ticipants, including pathologists, cyto-technologists, clinicians, and patientadvocates.

7 Forty-four professional so-cieties, representing more than 20 coun-tries, were cosponsors (BOX1). Morethan 20 national and international so-cieties have endorsed the 2001 BethesdaSystem at this writing. The followingsummary highlights the most clinicallyrelevant changes to the Bethesda Sys-tem (BOX2); a more detailed text willbe published in specialty 2001 Bethesda SYSTEMS pecimen AdequacyEvaluation of specimen adequacy isconsidered by many to be the singlemost important quality assurance com-ponent of the Bethesda system . Origi-nally, in 1988, specimen adequacy wascategorized as satisfactory, less thanoptimal (renamed satisfactory butlimited in1991), or unsatis-factory. The middle category was usedmost often for cases lacking endocer-vical or squamous metaplastic cells asevidence of transformation zone sam-pling, but which were otherwise sat-isfactory. The 2001 Bethesda Systemmaintains the satisfactory for evalua-tion and unsatisfactory for evalua-tion categories, but eliminates satis-factory but limited because theterm was considered confusing to manyclinicians and prompted unnecessaryrepeat testing.

8 Nevertheless, provid-ing information on transformation zonesampling has value in improving over-all specimen quality and encourages ef-forts to optimize sample squamous cellularity require-ments for a specimen to qualify as sat-isfactory differ depending on speci-men type: an estimated 8000 to 12 000well-visualized squamous cells for con-ventional smears and 5000 squamouscells for liquid-based preparations. Tech-niques for evaluating cellularity will bepresented in future notation is made regarding thepresence or absence of an endocervical/transformation zone component forspecimens with adequate squamous cel-lularity. The numeric criterion for aBOX1. Bethesda 2001 Workshop CosponsorsAmerican Cancer Society*American College Health Association*American College of Obstetricians and Gynecologists*American Social Health Association*American Society of Cytopathology*American Society for Colposcopy and Cervical Pathology*American Society of Clinical Pathologists*American Society for Cytotechnology*Asociacio n Mexicana de PatologosAssociation of Reproductive Health ProfessionalsAssociation of Women s Health, Obstetric and Neonatal NursesAustralian Society of CytologyBritish Society for Clinical CytologyCanadian Society of Cytology Socie te Canadienne de Cytologie*Centers for Disease Control and PreventionChinese Society of CytopathologyCollege of American Pathologists*Deutsche Gesellschaft fu r ZytologieFood and Drug AdministrationGynecologic Oncology Group.

9 ACOG*Health Care Financing AdministrationInternational Academy of CytologyInternational Society of Gynecological PathologistsIrish Association for Clinical Cytology*Japanese Society of Clinical CytologyKorean Society for CytopathologyMagyar Onkolo gusok Ta rsasa ga-Cytodiagnosztikai SectioNational Committee for Clinical Laboratory StandardsNurse Practitioners in Women s HealthO esterreichische Gesellschaft fuer Zytologie*Papanicolaou Society of Cytopathology*Planned Parenthood FederationRomanian Society of CytologySociedad Argentina de CitologiaSociedad Chilena de CitologiaSociedad Espan ola de Citologia*Sociedad Peruana de CitologiaSociedade Boliviana de CitologiaSociedade Brasileira de CitopatologiaSocieta` Italiana di Anatomia Patologica e Citopatologia DiagnosticaSocie te Belge de Cytologie Clinique Belgische Vereniging voor KlinischeCytologie*Socie te Franc aise de Cytologie Clinique*Society of Gynecologic Oncologists*Suid Afrikaanse Vereniging vir Kliniese Sitologie South African Society ofClinical Cytology**Indicates that the society has endorsed the 2001 Bethesda 2001 Bethesda system 2002 American Medical Association.

10 All rights reserved.(Reprinted) JAMA,April 24, 2002 Vol 287, No. 162115 at HSE: Health Service Executive (Ireland) on February 17, 2009 from transformation zone component is un-changed from the 1991 Bethesda Sys-tem there should be at least 10 well-preserved endocervical or squamousmetaplastic cells; however, clusters areno longer on quality indicators suchas partially obscuring inflammation orblood may also be added to the satis-factory designation. A specimen is con-sidered partially obscured when 50%to 75% of the epithelial cells cannot bevisualized. Specimens with more than75% of epithelial cells obscured are un-satisfactory. Specimens that cannot be acces-sioned by the laboratory, if unlabelledfor example, are also designated as un-satisfactory ; these are distinguishedfrom specimens that have been pro-cessed by the laboratory and deter-mined to be unsatisfactory followingmicroscopic CategorizationThe general categorization is an op-tional component of the Bethesda Sys-tem, designed to allow clinicians and/ortheir staff to triage reports readily.