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Introduction ⬇

Characteristic physiologic cellular changes occur in the female genital tract from birth through the postmenopausal years. Three major cell types occur in a characteristic pattern in normal vaginal smears:

  1. Superficial squamous cells are mature squamous, usually polygonal, containing a pyknotic (thick, compact, dense) nucleus.

  2. Intermediate squamous cells are mature squamous, usually polygonal, containing a clearly structured vesicular nucleus, which may be either well preserved or changed as a result of bacterial cytolysis.

  3. Parabasal cells are immature squamous, usually round or oval.

Findings indicate that presence of human papillomavirus (HPV) may be associated with the development of cervical cancer.

The Papanicolaou (Pap) cytologic smear is used principally for early detection of cervical cancer and diagnosis of precancerous and cancerous conditions of the vulva and vagina. The U.S. Preventive Services Task Force recommends conventional Pap tests every 3 years for women aged 21–65 years. Women aged 30–65 years may choose cotesting (Pap test plus HPV testing) every 5 years. After age 65 years with prior normal tests, they may choose to stop cervical screening (Table 11.2). This test is also used for diagnosis of inflammatory and infectious diseases. HPV testing is recommended for all women with a Pap cytologic diagnosis of atypical squamous cells of undetermined significance (ASC-US).

The value of the Pap smear depends on the fact that cells readily exfoliate (or can be easily stripped) from genital cancers. Cytologic study can also be used for assessing response to administered sex hormones. The microbiologic examination on cytology samples is not as accurate as bacterial culture, but it can provide valuable information.

Specimens for cytologic examination of the female genital tract are usually obtained by vaginal speculum examination or by colposcopy with biopsy. Material from the cervix, endocervix, and posterior fornix is obtained for most smears. Smears for hormonal evaluation are obtained from the vagina.

Clinical Alert

  1. Cytologic findings alone do not form the basis for a diagnosis of cancer or other diseases. Often, they are used to justify further procedures, such as biopsy.

  2. The Pap smear has been approved by the U.S. Food and Drug Administration (FDA) for diagnosis of cancer and HPV.

In an effort to standardize reporting of cervical-vaginal cytology specimens, the Bethesda System for reporting cervical-vaginal diagnoses was developed by a 1977 National Cancer Institute workshop and last revised in 2014. This reporting system has been adapted by many laboratories nationwide. The terminology of this reporting system appears in Chart 11.1. The Bethesda System 2001 recommends deleting hormonal evaluation. Hormonal evaluation is a crude measure of estrogen-like effects on squamous cells.

ThinPrep Pap Test (Hologic, Inc.) is the most widely used Pap test in the world. It is a liquid-based cytology method for Pap and HPV testing. The Pap smear collection device for ThinPrep is rinsed in a special solution and sent to the laboratory. A special machine prepares a uniform monolayer Pap smear. These slides are then manually screened in the usual manner. Studies have shown that ThinPrep smears have a higher rate of detection of biopsy-proven high-grade lesions and a lower rate of false-negative results than conventional Pap smears.

HPV has been identified as the primary causal factor in cervical cancer. Although there are more than 100 types of HPV, types 16 and 18 have been implicated in 70% of cervical cancers and types 6 and 11 in about 90% of genital warts. The digene HC2 High-Risk HPV DNA Test (QIAGEN Company) is approved in the United States for HPV DNA detection and can identify 13 of the high-risk types of HPV in cervical specimens: types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68.

Primarily, this test is useful to triage or manage women with an ASC-US or equivocal cytology result. It is an efficient, rapid test that is able to differentiate patients with high-risk versus low-risk HPV and can be performed from the same patient specimen when the ThinPrep Pap Test is used. In addition, the FDA has approved testing for Chlamydia trachomatis and Neisseria gonorrhoeae directly from the ThinPrep sample vial. If the ThinPrep Pap Test is not used, a collection kit is available from the QIAGEN Company. Clinicians should check with their laboratories for ordering and collection instructions for any of these tests.

Procedure ⬆ ⬇

  1. Ask the patient to remove clothing from the waist down. Provide appropriate covering.

  2. Place the patient in a lithotomy position on an examining table.

  3. Gently insert an appropriately sized bivalve speculum, lubricated and warmed only with water, into the vagina to expose the cervix (Figure 11.1).

  4. Observe standard precautions (see Appendix A).

  5. If a conventional Pap smear, as opposed to liquid base, is being taken, scrape the posterior fornix and the external os of the cervix with a wooden spatula, a cytobrush, or a cytobroom. Smear material obtained on glass slides and place immediately in 95% alcohol or spray fixative before air-drying occurs.

  6. If a ThinPrep Pap smear is being taken, use a broomlike collection device. Insert the central bristles of the broom into the endocervical canal deep enough to allow the short bristles to contact the ectocervix fully. Push gently and rotate the broom in a clockwise direction five times. Rinse the broom with a preservative solution vial by pushing the broom into the bottom of the vial 10 times, forcing the bristles apart. As a final step, swirl the broom vigorously to release material. Discard the collection device. Tighten the cap on the solution container so that the torque line on the cap passes the torque line on the vial.

  7. Label the specimen with the patient’s name, date and time of collection, test(s) ordered, and the area from which the specimen was obtained. Send the specimen to the laboratory with a properly completed information sheet, including date of collection, patient’s date of birth, date of last menstrual period, and pertinent clinical history.

  8. Tell the patient that the examination takes about 5 minutes.

  9. See Chapter 1 guidelines for intratest care.

Procedural Alert

  1. The best time to take a Pap smear is 2 weeks after the first day of the last menstrual period, not when the patient is menstruating or bleeding, unless bleeding is a continuous condition.

  2. Cytologic specimens should be considered infectious until fixed with a germicidal fixative. Observe standard precautions when handling specimens from all patients.

  3. A cytobrush should not be used to obtain a cervical specimen from a pregnant patient.

  4. Some nonpregnant patients experience heavy bleeding after a cytobrush is used.

Clinical Implications ⬆ ⬇

  1. Abnormal Pap cytologic responses include ASC-US and can be classified as protective, destructive, reparative (regenerative), or neoplastic.

  2. Inflammatory reactions and microbes (Trichomonas vaginalis and Monilia, Coccobacillus, Candida, and Actinomyces species, cells indicative of herpes simplex virus [HSV]) can be identified to help in the diagnosis of vaginal diseases and evidence of C. trachomatis and N. gonorrhoeae.

  3. Reactive cells associated with inflammation, typical surgical repair, radiation, intrauterine contraception devices, posthysterectomy glandular cells, atrophy, and endometrial cells in a woman aged 40 years or older.

  4. Positive DNA test for HPV.

  5. Precancerous and cancerous lesions of the cervix can be identified.

  6. Deviation from normal physiologic cell patterns may be indicative of a pathologic condition.

Interventions ⬆ ⬇

Pretest Patient Care

  1. Explain the Pap smear test purpose and procedure.

  2. Instruct the patient not to douche for 2–3 days before the test because douching may remove the exfoliated cells.

  3. Instruct the patient not to use vaginal medications or vaginal contraceptives during the 48 hours before the examination. Intercourse is not recommended the night before the examination.

  4. Have the patient empty the bladder and rectum before examination.

  5. Ask the patient to give the following information:

    1. Age—indicate if adolescent, pregnant, or postmenopausal

    2. Use of hormone therapy, birth control pills, or contraceptive devices

    3. Past vaginal surgical repair or hysterectomy

    4. All medications taken, including prescribed, over-the-counter, and herbal medications

    5. Any radiation therapy

    6. Any other pertinent clinical history (e.g., previous abnormal Pap smear, signs of inflammation or bleeding)

  6. Follow Chapter 1 guidelines for safe, effective, informed pretest care.

Posttest Patient Care

  1. Give the patient a moist towelette after the procedure to wipe away any bleeding or drainage.

  2. Review test results; report and record findings. Modify the nursing care plan as needed. Counsel the patient appropriately regarding repeat cytology testing if atypical or abnormal cells are present (Figure 11.2).

  3. Explain that monitoring and management of women with atypical or abnormal cells follows American Society for Colposcopy and Cervical Pathology consensus guidelines. Repeat HPV DNA tests and repeat cytology Pap smears are standard.

  4. Counsel the patient that treatment may include intravaginal estrogen therapy, diagnostic excisional procedures, or referral to an expert. Management options may vary if the woman is an adolescent, pregnant, or postmenopausal (see Chapter 12 for typical procedures).

  5. Explain to the patient and parent, as appropriate, that an HPV vaccine is available for girls and women aged 9–26 years who have not been exposed to HPV and that the vaccine is approved for the prevention of cervical cancer, cervical precancers, vaginal precancers, and genital warts.

  6. Follow guidelines in Chapter 1 for safe, effective, informed posttest care.

Interfering Factors ⬆ ⬇

  1. Medications such as tetracycline and digitalis, which affect the squamous epithelium, alter test results.

  2. The use of lubricating jelly in the vagina or recent douching interferes with test results by distorting the cells and preventing accurate evaluation.

  3. Heavy menstrual flow and blood may make the interpretation of the results difficult and may obscure atypical cells.

Reference Values ⬆

Normal Pap

No abnormal or atypical cells

No inflammation, no infection, no partially obscuring blood

Major cell types within normal limits

Negative for intraepithelial cell abnormality of malignancy

Negative for HPV