Bringing in Bethesda 2001: How the University of Kentucky made the switch
Bethesda System 2001
Diane D. Davey, MD
Bethesda 2001 terminology changes are now final, and many professional organizations, including the CAP, have endorsed them. While cytology professionals agree that the changes are positive for patient care, implementing the changes can be a laboratory challenge.
Training laboratory staff, educating physicians, and adjusting laboratory computer systems are the challenges. Training can consist of continuing education at national and regional meetings and on-site discussions and staff meetings. The final terminology table is shown on page 44. A number of publications and the Internet site http://bethesda2001.cancer.gov/ are also useful.
There is no specific target date for implementation, and some laboratories may choose to adopt changes over several months. At the University of Kentucky (UK) Cytology Laboratory, we decided to implement the changes in early October. Personnel issues and schedules were the main reasons we implemented the changes early.
UK uses the CoPath Plus computer system, and the interpretations are provided as menu choices. There are three menus: one mandatory menu for the main interpretation, another mandatory menu for specimen adequacy, and a third optional menu for additional descriptors. The final configuration of the report may vary between laboratories, but we found this system flexible enough to produce the desired result. A few weeks before the change, we reviewed our existing computer menu choices and discussed all the changes.
Laboratories using the general categorization will note the merging of the "within normal limits" and "benign cellular changes" categories and the addition of the "other" category. The "other" category is most commonly used for reporting of endometrial cells in women age 40 or older, and it’s helpful to specify whether the Pap is negative for SIL. UK has never used the general categorization (optional), but had always used a negative term for Paps in the "benign cellular changes" category. We replaced both the old negative descriptor and "within normal limits" with the new "negative for intraepithelial lesion or malignancy" term. Since our laboratory changed the heading for Pap reports from "diagnosis" to "interpretation" a few years ago, no change was needed here. Similarly, our specimen type and description already detailed whether the Pap was a smear or liquid specimen.
For the specific interpretation dictionary, the changes were easy. We eliminated any choices including "favor reactive" tied to the "atypical" term, though such terms were discouraged some time ago. We added new terms such as "endocervical adenocarcinoma in situ" and "HSIL with features suspicious for invasion." We simply substituted our former non-Bethesda phrase "atypical metaplasia, cannot rule out HSIL" for the new term "atypical squamous cells—cannot exclude HSIL." Minor changes were also made for organisms, endometrial cell entries, and nonneoplastic descriptors.
Implementing the adequacy changes was more of a challenge. Our computer system allows us to choose several adequacy descriptors but only one default. We arranged all of the main satisfactory terms at the top of the menu as follows and made the first one the default:
- Satisfactory for evaluation; endocervical/transformation zone
- Satisfactory for evaluation; endocervical/transformation zone component
- Satisfactory for evaluation (vaginal Pap).
Note that words in parentheses appear on the menu but not on the report.
One challenge is that cytotechnologists need to remember to change the default and choose the correct designation when screening a satisfactory vaginal Pap. We also provided training and diagrams related to new squamous cellularity criteria for both conventional and liquid-based Paps. The average number of cells per 40 field to achieve an estimated 5,000 cells on liquid preps was determined for each microscope in the laboratory. Luckily, we find that the time impact is small since few Paps have questionable cellularity.
All references to "satisfactory but limited by" were replaced with descriptive quality indicators such as "partially obscuring inflammation present." These are listed lower in the menu so that they will be selected second and will always appear after the "satisfactory" entry. Minor changes in unsatisfactory terminology were made to accommodate Bethesda 2001 recommendations.
One week before implementation, we prepared an educational memo for all clinicians in the UK system (see below). This is by no means a complete discussion; our aim was to keep it brief and readable. It was distributed by e-mail to all physicians, and hard copies were mailed in addition to select physicians performing Paps. All computer changes were made in one weekend so that we were ready to proceed Monday morning, and the supervisor and I allotted time to answer last-minute questions. After the e-mail letter was distributed, I received a few return e-mails thanking me for the information and an invitation to provide a continuing education conference. We received only a few phone calls from office staff who didn't read their e-mail or weren't on the e-mail distribution list, and we faxed memos to them. To date we have not had any significant complaints or problems.
The 2002 Interlaboratory Comparison Program in Gynecologic Cytopathology (PAP) will introduce the Bethesda 2001 terminology for interpretation of Pap tests. You will notice a few changes in the answer forms, especially for the specimen adequacy designation. PAP shipments will include a detailed summary of Bethesda 2001 adequacy terminology, criteria, and rules.
Dr. Davey is past chair of, and now 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.