33.0 ThinPrep Pap Test Imaging


Title of Manual: Specimen Collection

Version No: 1.1

Title: ThinPrep Pap Test w/Imaging

Effective Date: 11/01/09
Revised Date: 12/30/13

Document #: GPA.SPC.33.0


I. PURPOSE

To provide proper collection protocol for ThinPrep Liquid Based Pap.

II. MATERIALS

Reagents

Supplies

Equipment

CytoBrush & Spatula or
Broom in ThinPrep Liquid
Based Collection Vial


III. PROCEDURE

1. Label the vial with patient’s name, date of birth or requisition ID #. Complete a test requisition.
2. It is essential to provide all pertinent clinical information, such as diagnosis code, LMP, clinical history,
    and high risk factors.
3. The ThinPrep Pap test should ideally be taken two weeks after the first day of the last menstrual period.
    The patient should avoid the use of vaginal medications, vaginal contraceptives, douches, lubricants,
    and sexual intercourse at least 48 hours prior to examination. NCCLS guidelines recommend that no
    lubricant be used during the pap test. ACOG recommends that care be taken not to contaminate the
    specimen with lubricant because this may lead to an unsatisfactory result and insufficient specimen
    remaining for ancillary testing.
4. Tighten the cap so that the torque black line on the cap passes the torque line on the vial.
5. At the end of the procedure place the vial into a biohazard specimen bag along with the requisition in
    the side pocket.

Endocervical Brush / Spatula Protocol:
Insert plastic spatula into the cervical os and rotate one full turn (360 degrees). Rinse the spatula into the ThinPrep vial by swirling the spatula vigorously 10 times. Discard the spatula; do not attempt to remove the device head and leave in the vial. Doing so may interfere with sample processing.

Insert cytobrush, (recommended to obtain Endocervical cells) into Endocervix. Gently rotate ¼ turn to ½ turn in one direction. Do not over-rotate. Rinse the brush into the ThinPrep vial by rotating the device in the solution ten times while pushing against the vial wall. Swirl the brush vigorously to further release material. Discard the brush; do not attempt to remove the device head and leave in the vial. Doing so may interfere with sample processing.

Broom-Like Device Protocol:
Insert the central bristles of the broom into the endocervical canal deep enough to allow the shorter bristles to fully contact the ectocervix. Push gently, and rotate the broom in a clockwise direction five times. Rinse the broom into the ThinPrep vial by pushing the broom into the bottom of the vial ten times, forcing the bristles apart. As a final step, swirl the broom vigorously to further release material. Discard the collection device; do not attempt to remove the device head and leave in the vial. Doing so may interfere with sample processing.

IV. QUALITY CONTROL

• Minimum Volume:
    • 20 mL
• Storage Requirements:
    • Room Termperature
• Stability Requirements:
    • 4 Weeks

V. CALCULATIONS/CALIBRATION

VI. INTERPRETATIONS

VII. METHOD PERFORMANCE SPECIFICATIONS

VIII. REFERENCES

IX. RELATED DOCUMENTS

TP Collection E:11/1/09

X. DOCUMENT HISTORY

MINOR REVISION
(Laboratory Director’s Signature on Original Subsequent Document Attached)

X - MAJOR REVISION
(Requires Laboratory Director & Department Director Signature - where applicable)

Reason for Change

12/30/14 New Document Control Format



Laboratory Director

(Signature)

Date

Natalie Depcik-Smith, MD
(Print)



Department Director

(Signature)

Date


(Print)



Designee

Date

(Print)

(Signature)

(Print)

(Signature)

(Print)

(Signature)

(Print)

(Signature)

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(Signature)



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