5.0 Breast Biopsy


Title of Manual: Specimen Collection

Version No: 2.0

Title: Breast Biopsy

Effective Date: 11/01/09
Revised Date: 02/27/14

Document #: GPA.SPC.5.0


I. PURPOSE

To provide directions for the proper collection of breast tissue for pathology review.

II. MATERIALS

Reagents

Supplies

Equipment

• Sterile container with 10% Neutral buffered formalin


III. PROCEDURE

The specimen must be submitted in ten percent neutral buffered formalin. Formalin containers must have a formalin hazard label on the outside of the container. The amount of formalin should be fifteen to twenty times the volume of the specimen.

If a mass is present, do not cut into or remove any of the tumor.

Please see requisition form instructions for complete information. Complete test requisition including last and first name of patient, patient’s date of birth and social security number, body site and source of specimen collected. Label specimen container (using the labels provided on the requisition) with patient’s first and last name, and body site/source. Include pertinent clinical information, i.e., previous malignancy, radiation therapy, drugs, etc. Place container in a specimen bag with a biohazard label. Place the requisition in the side pocket of the specimen bag.

IV. QUALITY CONTROL

Minimum Volume: 0.1 X 0.1 X 0.1 cm

Store above freezing in 10% Neutral Buffered Formalin.

The time the specimen was placed into the formalin must be documented on the requisition. Since these specimens may require Her2 testing, their fixation must be no less than 6 hours and no more than 48 hours per CAP #ANP.22998. As a consequence, there are special procedures for samples that come in at the end of the week or before a Holiday. See the grossing procedures.

V. CALCULATIONS/CALIBRATION

VI. INTERPRETATIONS

VII. METHOD PERFORMANCE SPECIFICATIONS

VIII. REFERENCES

IX. RELATED DOCUMENTS

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

02/27/14 New Document Control Format



Laboratory Director

(Signature)

Date

Natalie Depcik-Smith, MD
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Department Director

(Signature)

Date


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Designee

Date

(Print)

(Signature)

(Print)

(Signature)

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(Signature)

(Print)

(Signature)

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(Signature)



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