GYN CYTOLOGY
WPM Pathology Laboratory performs a large volume of Pap tests every year while maintaining a reputation for very rapid turn-around-time, accurate reporting and easy telephone accessibility of Cytologists and Pathologists. We provide monthly summary reports as an addition to our service. PCR testing for HPV, Chlamydia Trachomatis (CT), Neisseria Gonorrhea (NG), Herpes Simplex Virus (HSV), and Vaginosis Diagnostic Panel (VDP) including Candida, Garderella and Trichomonas are available through our Cytology department.
THE PAP SPECIMEN
The pap test is one of the most successful laboratory test developed in the last fifty years. The noninvasive nature, the simplicity of the smear plus low cost is the key to its success. Annual pap tests have reduced the chances of developing invasive cervical carcinoma by 95% and have reduced the cervical cancer mortality rate by 70 % since it was introduced in the United States in the 1940’s. Cervical cancer went from a leading cause of death in women in the United States to thirteenth. Worldwide, cervical cancer remains the second most common cancer in women and is first in many developing countries. Even though squamous cell carcinoma was the targeted disease, other cervical malignancies, precursors to cervical carcinoma and certain sexually transmitted diseases can be identified. 1 Cervical Cytology practice Guidelines, American Society of Cytopathology, Nov. 10, 2000. Web page: www.cytopathology.org/guidelines/guide_cervical_cytology.php
Frequency of screening of a particular patient should be determined by the physician and patient after a thorough risk assessment. HPV status is the major factor in the development of cervical cancer.
OTHER RISK FACTORS INCLUDE
PATIENT PREPARATION
Reaffirmed April 2024 - Recommendations for patients at average-risk:
AGE 21-29: Pap Test every 3 years with recommended hrHPV after age 25 every 5 years
AGE 30-65: (A) Pap Test every 3 years OR (B) Pap Test and co-testing with hrHPV every 5 years OR (C) Primary hrHPV testing every 5 years
AGE 70+: Pap testing can stop if they have had 3 or more normal Pap Test results in the past 10 years
Management of patients with above average risk or with abnormal cervical screening results should follow current ASCCP guidelines.
CRITERIA FOR REJECTION
Rejected Pap specimens will be logged in to WPM’s Rejection Log and returned to the client with an explanation of rejection. Specimens will be rejected for the following reasons:
REQUISITION
A properly completed requisition is essential to good patient care. The top sections of the requisition include patient identification information and billing information. The bottom section provides space for you to order tests and supply current and past history.
TRANSPORT
Once the SurePath vial has been properly identified, place in a specimen biohazard bag. The requisition is folded in half and placed in the outside pouch. It is important that the requisition be completely filled out. See REQUISITION.
COLLECTION PROCEDURE for Liquid-Based Pap
NOTE: Cytological specimens should be considered infectious until fixed with a germicidal fixative. Observe universal precautions when handling specimens from all patients.
- Fill out requisition completely and label slide with patient’s name.
- Avoid palpating the cervix before obtaining the pap test.
- Insert appropriate sized speculum without lubricant. The speculum may be moistened slightly with warm tap water.
- Examine the cervix completely, using a tenaculum to straighten cervix, if necessary. If there is excess mucus or other discharge present it should be gently removed with a ring forceps holding a folded gauze pad. Inflammatory exudates may be removed by placing a dry 2 X 2 piece of gauze over the cervix and peeling it away after it absorbs the exudates, or by using a dry protoswab or scopette. The cervix should not be cleaned by washing with saline as it may result in a relatively acellular sample.
- Take the pap test before taking other tests from the cervix. The recommended order for specimen collection is:
- Vaginal pH
- Vaginal wet smear
- pap test
- Gram stain of cervix
- Gonorrhea culture
- Chlamydia sample
- Insert the Rovers Cervex-Brush™ into the endo-cervical canal.
- Apply gentle pressure until the bristles form against the cervix.
- Maintaining gentle pressure, hold the stem between the thumb and forefinger and rotate the brush five times in a clockwise direction.
- Placing your thumb against he back of the brush pad, simply disconnect the entire brush from the stem into the SurePath™ vial.
- Place the cap on the vial and tighten. Label the vial with patient’s name, physician and date.
- Place the vial into a specimen bag and place the requisition in the outside pocket and send to the laboratory.
MEDICARE RELEASE FOR A SCREENING pap test
- If the patient has Medicare, please review the requirements for a SCREENING pap test, HIGH RISK pap test AND A DIAGNOSTIC pap test with your patient. The back of the white copy has the Advanced Beneficiary Notice (ABN) and two boxes to choose from plus the patient signature line.Medicare will only reimburse for a SCREENING pap test under one of the following conditions:
- Once every two years
- Or if there is evidence (on the basis of the medical history or other findings) that she is of childbearing age and has had as examination that indicated the presence of cervical or vaginal cancer or other abnormalities during any of the preceding 2 years, or that she is at high risk of developing cervical or vaginal cancer.
- Cervical Cancer High Risk Factors:
- Early onset of sexual activity (under 16 years of age)
- Multiple sexual partners (five or more in a lifetime)
- History of sexually transmitted disease (including HIV infection)
- Fewer than 3 negative pap tests within the previous 7 years
- Vaginal Cancer High Risk
- DES (diethylstilbestrol) exposed daughters of women who took DES during pregnancy
- Cervical Cancer High Risk Factors:
A DIAGNOSTIC pap test and related medically necessary services continue to be covered under Medicare Part B when ordered by a physician under one of the following conditions:
- Previous cancer of the cervix, uterus or vagina that has or is presently being treated
- Previous abnormal pap test
- Any abnormal findings of the vagina, cervix, uterus, ovaries or adnexa
- Any significant complaint by the patient referable to the female reproductive system
- Any signs or symptoms that might in the physician’s judgment reasonably be related to gynecologic disorder
- (In respect to this item, each case will be reviewed to determine whether a previous malignancy at another site is an indication for a DIAGNOSTIC pap test or whether the test must be considered a SCREENIG pap test.)
MATERIALS for Liquid-Based Sample
- GYN CYTOLOGY REQUST form
- Collection vial
- Appropriate collection devices as supplied and approved by the liquid-based method
TURN AROUND TIME
Most Pap specimens will have a report issued with 2 to 3 working days of specimen receipt. Specimens requiring Pathologist review will require more time. If you need results immediately, please call the Cytology department at WPM and we will examine the Pap specimen ASAP.
GYNECOLOGICAL CYTOLOGY REPORTING
The 2001 Bethesda System (TBS) is the cytology reporting system used by WPM Pathology Laboratory to report results of gynecological cytology. The following definitions for each category are used:
SPECIMEN ADEQUACY
- “SATISFACTORY FOR EVALUATION” indicates that the specimen has all of the following:
- Appropriate labeling and identifying information.
- Relevant clinical information.
- Adequate number of well-preserved and well-visualized squamous epithelial cells. Minimal requirements for the conventional smear are an estimated 8,000-12,000 well-visualized squamous epithelial cells and 5,000 squamous cells for liquid-based preparations.
- At least ten well-preserved endocervical or squamous metaplastic cells are present. A notation is made under Specimen Adequacy regarding the absence of the endocervical component if no endocervical or metaplastic cells are identified.
- Other quality indicators where a notation may be made in the report include the presence of inflammation, blood or foreign material that may be partially obscuring 50-75% of the sample area.
- “UNSATISFACTORY” indicates that the specimen has one of the following:
- Scant squamous epithelial component (well- preserved and well-visualized cells covering less than 10% of the slide surface.)
- Obscuring blood, inflammation, thick areas, poor fixation, air-drying artifact, contaminant, etc… that precludes interpretation of approximately 75% or more of the epithelial cells.
INTERPRETATION
- NEGATIVE FOR INTRAEPITHELIAL LESION OR MALIGNANCY indicates no squamous or glandular epithelial abnormality is identified.
- “REACTIVE AND OR REPARATIVE CELLULAR CHANGES NOTED” will appear as an additional comment under this interpretation in the section titled “ADDITIONAL FINDINGS.” Reactive changes that are benign in nature, associated with inflammation (includes typical repair), atrophy with inflammation (“atrophic vaginitis”), radiation, an IUD, and other nonspecific causes. This designation includes reparative changes or “typical repair”, which may involve squamous epithelium, squamous metaplasia or columnar epithelium.
- ATYPICAL SQUAMOUS CELLS- UNDETERMINED SIGNIFICANCE ASC-US is defined as cytologic changes suggestive of a LSIL (Low Grade Squamous Intraepithelial Lesion) that are quantitatively or qualitatively insufficient for a definitive diagnosis.
- ATYPICAL SQUAMOUS CELLS- CANNOT EXCLUDE HIGH GRADE INTRAEPITHELIAL LESION ASC-H is defined as cytologic changes suggestive of HSIL that are quantitatively or qualitatively insufficient for a definitive diagnosis.
- ATYPICAL GLANDUALR CELLS OF ENDOCERVICAL ORIGIN
- ATYPCIAL GLANDUALR CELLS OF ENDOMETRIAL ORIGIN
- ATYPICAL ENDOCERVICAL CELLS, FAVOR NEOPLASTIC
Defined as suggestive, but not diagnostic of Adenocarcinoma in situ. - ATYPICAL ENDOMETRIAL CELLS, FAVOR NEOPLASTIC
Defined as suggestive, but not diagnostic of Adenocarcinoma in situ. - SQUAMOUS INTRAEPITHELIAL LESION
- Low grade
- High grade
- SQUAMOUS CELL CARCINOMA
- ADENOCARCINOMA
A malignant tumor of glandular cells. - MALIGNANT NEOPLASMS, NOS
Malignant cells of uncertain histogenesis.
ADDITONAL FINDINGS
ANCILLARY TESTING
All ancillary testing comments and results will be reported here.
HPV Human Papilloma Virus
Making sense of HPV testing is a daunting task. As scientists learn more about the etiology of HPV, laboratories are offering more options for testing. HPV information is flooding the literature, including medical journals, woman’s magazines, and health reports on television and radio. The general public and your patients are asking more informed questions about HPV testing.
So how do clinicians and patients answer all the questions? Where do you find the answers and whom can you trust? We, at WPM Pathology Laboratory, have tried to answer some common questions posed by both your patients.
What is HPV?
HPV is a common sexually transmitted disease throughout the world. In the United States it is the most common STD, affecting more than 20 million individuals. About 400,000 new cases are diagnoses annually. HPV is widely accepted as the primary agent involved in the development of squamous intraepithelieal lesions and cervical carcinoma. According to the ALTS report, approximately 87% of all LGSIL lesions are positive for HPV.
Currently, more than 120 different genotypes are known. Forty to fifty types are identified as infecting the urogenital tract. Currently, about twenty types are believed to be involved in the genesis of cervical cancer.
Why order HPV testing?
HPV testing is ordered to determine the presence of Human Papilloma Virus. Many other factors can contribute to an ASC-US pap test; therefore, it is helpful to determine the presence of HPV. It is also ordered to estimate the risk of developing a significant lesion in the future. HPV testing, with genotyping, can help you triage follow-up care for your ASC-US patients and provide risk assessment for LSIL patients. PCR genotyping also allows for following persistent infections, recurrent infections and identifying new infections in patients with on going atypical Pap results.
How To Order HPV Testing
Our GYN Cytology requisition gives the clinician several options for ordering reflex testing at the time of collection of a liquid-based Pap. By marking one of these options, WPM will automatically order HPV testing accordingly. Clinicians may also use the ANCILLARY TESTING REQUISTION to order HPV testing on selected patients.