31.0 SurePath Pap Test


Title of Manual: Specimen Collection

Version No: 1.1

Title: SurePath Pap Test

Effective Date: 11/01/09
Revised Date: 01/02/14

Document #: GPA.SPC.31.0


I. PURPOSE

To provide proper collection protocol for the SurePath Liquid Based Pap Test.

II. MATERIALS

Reagents

Supplies

Equipment

CytoBrush & Spatula or
Broom in SurePath 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 SurePath 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.
4. Be certain to tighten the cap 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 the contoured end of the plastic spatula and rotate 360° around the entire ectocervix. Detach the device into the SurePath preservative vial. Insert Cytobrush into the endocervix until only the bottom-most bristles are exposed at the os. Slowly rotate ¼ to ½ turn in one direction. To reduce unnecessary bleeding, do not over-rotate brush. Detach the device handle and drop the detachable head of the device into the Sure Path vial.

Broom-Like Device Protocol:
Insert the central bristles of the Rovers Cervix-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. Detach the head of the device into the Sure Path vial.

IV. QUALITY CONTROL

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

V. CALCULATIONS/CALIBRATION

VI. INTERPRETATIONS

VII. METHOD PERFORMANCE SPECIFICATIONS

VIII. REFERENCES

IX. RELATED DOCUMENTS

SP Collection Guide 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

1/2/14 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)

(Print)

(Signature)



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