THE PAP SPECIMEN

The Pap smear 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 smears 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 Cervical Cancer Screening Policy
College of American Pathologists
Revised February 2003

The College of American Pathologists encourages annual pelvic exams and regular cervical cancer screening for all women. Regular cervical cancer screening should begin three years after women become sexually active or by the age of 21. Current data indicate that most women under the age of 30 will benefit from annual cervical cancer screening. Lengthened intervals of cervical cancer screening may be appropriate for some women depending upon specific clinical circumstances.

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.

Major Risk Factors

  • Exposure to Human Papillomavirus (HPV)
  • Early age of sexual intercourse
  • Multiple sex partners
  • Sexual intercourse with men whose past partners have had abnormal Pap smears or cancer of the cervix
  • Exposure to diethylstilbestrol (DES) before birth
  • Smoking cigarettes
  • Oral contraceptives

PATIENT PREPARATION

Preferably an ideal Pap smear should be taken under these conditions:

  • Patient should not be on menses, make an appointment 1-2 weeks after first day of period.
  • No contamination of the cervix during the previous 48 hours from birth control foams, jellies, creams, lubricants, medications, or semen.
  • No recent abrasion of the cervix in the last 48 hours due to sexual intercourse or douching.
  • No cervicitis (if present, treat first and have the patient return 4-6 weeks later near mid cycle).

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:

  • No requisition available
  • Inadequate identification
    • Different names on smear, container or requisition
  • Specimen not properly fixed
  • Specimen received from an unauthorized source

MATERIALS for Conventional Smears

  • GYN CYTOLOGY REQUST form
  • Glass slides with frosted end
  • Ayre spatula for ectocervix- either plastic or wooden
  • Endocervix sampler (Cervical brush or broom or spatula with extended tip)
  • Fixative
  • OR a PAP Pak Kit- available from this laboratory

LABELING

All Pap specimens must be properly labeled per federal regulations.

A properly labeled Pap-Pak Kit will include the following:

  1. Patient’s last name and first name written on the outside of the Pap Pak Kit
  2. Patient’s last name and first initial written in pencil on the frosted end of the slide

A properly labeled liquid-based specimen will include the following:

  1. Patient’s last name and first initial
  2. Date of collection

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.

  • Please use patient’s complete and legal first name as it appears on insurance information.
  • If you wish to reference YOUR chart number supply that in the box labeled: PATIENT ID NUMBER.
  • Supply all current insurance information. Copies of the card(s) are very helpful or your billing face sheet may be attached. Be sure to include insured date of birth.
  • If the patient has Medicare, please review the requirements for a SCREENING PAP SMEAR, HIGH RISK PAP SMEAR AND A DIAGNOSTIC PAP SMEAR 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.
  • Clinical information as well as test requested need to be completed next.
    • Be sure to mark what test you are ordering.
    • Complete SOURCE OF SPECIMEN
    • COLLECTION DATE MUST be completed.
    • Supply DIAGNOSIS CODE
    • LMP is required.
    • All other pertinent clinical information

STORAGE

Once a Pap smear has been collected and properly fixed with the supplied spray fixative, it may be stored at room temperature for an indefinite period of time. It is important to note: Pap slides must not be stored or transported in the same secondary containers as formalin fixed tissue samples.

A Pap specimen in a liquid-base (SurePath) vial may be stored at room temperature for an indefinite period of time.

TRANSPORT

Once the Pap Pak Kit or 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 Conventional Smear

NOTE: Cytological specimens should be considered infectious until fixed with a germicidal fixative. Observe universal precautions when handling specimens from all patients.

  1. Fill out requisition completely and label slide with patient’s name.
  2. Avoid palpating the cervix before obtaining the Pap smear.
  3. Insert appropriate sized speculum without lubricant. The speculum may be moistened slightly with warm tap water.
  4. 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.
  5. Take the Pap smear before taking other tests from the cervix. The recommended order for specimen collection is:
    • Vaginal pH
    • Vaginal wet smear
    • Pap smear
    • Gram stain of cervix
    • Gonorrhea culture
    • Chlamydia sample
  6. Sample the ectocervix with the spatula. See following diagram.
    • Scrape with the spatula 360 degrees around the cervix at least once.
    • Use firm pressure.
    • Multiple scrapes may be necessary in parous cervix or with a wide ectopy.
    • Withdraw the collection device carefully, avoiding vaginal contamination.
  7. Sample the Endocervix. See following diagram.
    • Insert the collection device of choice far enough into the canal to include the entire transformation zone, especially in postmenopausal women.
    • Rotate or swab vigorously to obtain the cells, turning the swab or brush counterclockwise in the cervix.
    • Withdraw the device carefully, avoid vaginal contamination.
  8. Apply the spatula sample to the slide in an arching circular motion with moderate pressure to make a uniform, thin specimen.
  9. Apply the endocervical specimen beside the ectocervical material. If a swab or brush is used, use moderate pressure to roll the material onto the slide with a clockwise motion and sweep in an arch across the slide.
  10. Fix within 1-2 seconds of applying specimens to slide by completely covering the slide with fixative.
  11. Allow the fixed slide to air dry completely before packaging.
  12. If the woman has had a hysterectomy, sample the vaginal cuff.

MATERIALS for Liquid-Based Sample

  1. GYN CYTOLOGY REQUST form
  2. Collection vial
  3. Appropriate collection devices as supplied and approved by the liquid-based method

COLLECTION PRICEDURE 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.

  1. Fill out requisition completely and label slide with patient’s name.
  2. Avoid palpating the cervix before obtaining the Pap smear.
  3. Insert appropriate sized speculum without lubricant. The speculum may be moistened slightly with warm tap water.
  4. 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.
  5. Take the Pap smear before taking other tests from the cervix. The recommended order for specimen collection is:
    • Vaginal pH
    • Vaginal wet smear
    • Pap smear
    • Gram stain of cervix
    • Gonorrhea culture
    • Chlamydia sample
  6. Insert the Rovers Cervex-Brush™ into the endo-cervical canal.
  7. Apply gentle pressure until the bristles form against the cervix.
  8. Maintaining gentle pressure, hold the stem between the thumb and forefinger and rotate the brush five times in a clockwise direction.
  9. Placing your thumb against he back of the brush pad, simply disconnect the entire brush from the stem into the SurePath™ vial.
  10. Place the cap on the vial and tighten. Label the vial with patient’s name, physician and date.
  11. Place the vial into a specimen bag and place the requisition in the outside pocket and send to the laboratory.

MATURATION INDEX

To obtain sample for a Maturation Index, a specimen should be collected from the upper 1/3 lateral vaginal wall. The sample should then be placed on a separate slide and labeled appropriately as MI or VAG.

MEDICARE RELEASE FOR A SCREENING PAP SMEAR

If the patient has Medicare, please review the requirements for a SCREENING PAP SMEAR, HIGH RISK PAP SMEAR AND A DIAGNOSTIC PAP SMEAR 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 SMEAR 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 smears within the previous 7 years
    • Vaginal Cancer High Risk
      • DES (diethylstilbestrol) exposed daughters of women who took DES during pregnancy

A DIAGNOSTIC PAP SMEAR 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 smear
  • 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 SMEAR or whether the test must be considered a SCREENIG PAP SMEAR.)

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.

contact us

  • WPM Pathology Laboratory
  • 338 N. Front St.
  • Salina, KS 67401
  • 785.823.7201