Cervical / Vaginal Specimens

LabCorp uses the Bethesda 2014 System of reporting cervical/vaginal cytology specimens. We believe that Bethesda 2014 promotes consistent communication and clarity in reporting cervical cytopathology results. This updated reporting system is a further refinement of “The Bethesda System” recommended by the National Cancer Institute in 1991 (enhancements are depicted in the accompanying table.) The 2014 Bethesda System update has been expanded and revised to take into account the advances and experiences in the past decade, while clarifying various technologies and morphologic questions. At LabCorp, reporting of test options for cervical/vaginal cytology is based on the 2012 ASCCP Consensus Guidelines Conference. ¹

All primary specimen containers (vials) must be labeled with two identifiers at the time of collection. Submitted slides may be labeled with a single identifier, but two identifiers are preferred. Examples of acceptable identifiers include—but are not limited to—patient's name (patient's first and last name exactly as they appear on the test request form), date of birth, hospital number, test request form number, accession number, or unique random number. A location (eg, hospital room number) is not an acceptable identifier. (Note: The primary specimen container received by the laboratory is the innermost container that actually holds the specimen.)

Consequently, the patient's name must be clearly written on the frosted end of the slide(s) or on the liquid-based collection container(s) and vial(s). Unidentified cases will be returned to the physician's office unprocessed. Please ensure that all liquid-based vials are within the manufacturer-labeled expiration date. Please note the patient's date of birth on the test request form. This patient's information will aid in compiling and maintaining a five-year data base for retrieval of previous cytology reports.

Note: In accordance with criteria established by CLIA, Pap smears will be referred for pathologist review if laboratory personnel suspect (1) reactive or reparative cellular changes, (2) atypical squamous or glandular cells of undetermined significance, or (3) cells in the premalignant or malignant category. In these cases, concomitant CPT code(s)/charge(s) will apply. (Slides that are routinely reviewed by a pathologist for quality control purposes are not included.)

The 2014 Bethesda System for Reporting Cervical / Vaginal Cytology

Specimen Type

• Indicate conventional smear (Pap smear), liquid-based preparation (Pap test), or other.

Specimen Adequacy

• Satisfactory for evaluation (Describe presence or absence of endocervical/transformation zone component and any other quality indicators, eg, 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 source.)

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 (eg, endometrial cells in a woman ≥45 years of age).

Computer-assisted Interpretation of Cervical Cytology

• If case is 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 (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.

Other Non-neoplastic Findings (Optional to report; list not inclusive)

• Squamous metaplasia
• Keratotic changes
• Tubal metaplasia
• Atrophy
• Pregnancy-associated changes
• Reactive cellular changes associated with inflammation (includes typical repair)
• Lymphocytic (follicular) cervicitis
• Radiation
• Intrauterine contraceptive device (IUD)
• Glandular cells status posthysterectomy

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 (HSV)
• Cellular changes consistent with cytomegalovirus

Other

• Endometrial cells (in a woman ≥45 years of age). Specify if “negative for squamous intraepithelial lesion.”

Epithelial Cell Abnormalities

Squamous Cell

• Atypical squamous cells of undetermined significance (ASC-US)
• Atypical squamous cells of undetermined significance, 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 (not otherwise specified [NOS], or Specify in comments.)
• Atypical endometrial cells (NOS, or Specify in comments.)
• Atypical glandular cells (NOS, or Specify in comments.)
• Atypical endocervical cells, favor neoplastic
• Atypical glandular cells, favor neoplastic
• Endocervical adenocarcinoma in situ
• Adenocarcinoma endocervical
• Adenocarcinoma endometrial
• Adenocarcinoma extrauterine
• Adenocarcinoma NOS

Other Malignant Neoplasms (Specify)

Educational Notes and Suggestions (Optional)

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