Tissue Pathology

1. Obtain biopsy(ies) with care not to crush the specimen with forceps, hemostats, or other instruments. Cautery will cause heat artifact.

2. After biopsy collection, immediately place each specimen in a tightly secured container with 10% neutral buffered formalin. Use only formalin bottles supplied by Quest Diagnostics. Do not force a large specimen into a small container; formalin must surround the specimen for proper fixation. Formalin volume to specimen ratio should be 10:1.

3. Use a separate container for each separately identified specimen. Specialized Collection kits are available for prostate, GI and Hematopathology specimens.

4. Two forms of patient ID are required by the College of American Pathologists (CAP). Label primary* specimen container wall (not the lid) with the patient’s name and one (1) other unique identifier that also appears on the requisition and the source of specimen at the time of collection. Place one (1) of the peel-off labels from the Test Requisition onto each specimen container, if available.

Submitted slides must be labeled with two (2) acceptable positive patient identifiers at the time of collection. Examples of acceptable identifiers include, but are not limited to, patient name, date of birth, hospital chart number, social security number, requisition number, accession number, unique random number or clinical chart numbers that identify the patient from whom the laboratory specimen was obtained. A location (e.g., hospital room number) or specimen site is not an acceptable identifier.

 *Primary specimen container is the innermost container received by the laboratory that actually holds the specimen.

5. Do NOT freeze formalin-fixed specimens.

6. Complete a Tissue Pathology Test Requisition and send with specimen(s). Only 1 Tissue Pathology Test Requisition per patient is needed. Each container and specimen must be separately identified on the Test Requisition. Ensure patient name and site are an exact match on each container and each requisition before submitting or transporting.

The Test Requisition should reflect pertinent demographic and clinical information, including:

• Patient’s full first and last name (any name change should be noted) and unique identifier
• Patient’s date of birth
• Gender
• Date of specimen collection; the time of collection is also required for breast biopsies where a subsequent molecular test such as ER/PR may be performed (see below for additional requirements)
• Clinical/ pre- op diagnosis (duration, size, impression)
• Pertinent clinical history/operative findings and/or previous surgery
• Specific anatomic location of tissue removed and
• The procedure (excision, cone, punch, etc)
• Any requests for additional special studies 

Specialty Requisitions for Uropathology, GI Pathology, Dermatopathology and Hematopathology are available in addition to the general Histopathology Test Requisition. These requisitions generally differ by using checkboxes for clinical symptoms/history related to each specialty.

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Immunofluorescence testing is handled by only a few local Quest Diagnostics laboratories. Contact your regional Quest Diagnostics Supply Department and request Michel’s Fixative prior to biopsy. Immunofluorescence cannot be performed on formalin-fixed tissues.

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Frozen sections are handled by only a few local Quest Diagnostics laboratories. Contact your regional laboratory to determine if this service is available in your area.

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Place the tissue specimen in 10% formalin fixative immediately upon collection. Label primary* specimen container wall (not the lid) with two (2) acceptable positive patient identifiers and the source of specimen at the time of collection. Place one (1) of the peel-off labels from the Test Requisition onto each specimen container, if available. 

Submitted slides must be labeled with two (2) acceptable positive patient identifiers at the time of collection. Examples of acceptable identifiers include, but are not limited to, patient name, date of birth, hospital chart number, social security number, requisition number, accession number, unique random number or clinical chart numbers that identify the patient from whom the laboratory specimen was obtained. A location (e.g., hospital room number) or specimen site are not an acceptable identifier. 

*Primary specimen container is the innermost container received by the laboratory that actually holds the specimen.

Avoid decalcifying procedures which may affect results. Avoid freezing or crushing artifacts. Alternatively, submit a formalin-fixed, paraffin-embedded tissue block or one (1) routinely stained (hematoxylin and eosin) histologic section of the block and 5 each 4-micron freshly cut unstained sections on positively charged slides. Do not oven dry unstained slide(s) before sending out for testing. Include a completed Test Requisition with appropriate clinical history and a copy of the original requisition and pathology report with interpretation (when submitting blocks and slides).

Indicate the following on the Test Requisition:

• Time and date of collection (comment if unknown)
• Cold ischemia time (time between removal and fixation)
• Type of fixation if other than formalin (comment if unknown)
• Duration of fixation (number of hours from time of collection/fixation to time of processing of tissue sample). Alternately, specify that fixation is no less than 6 hours and no more than 48 hours for HER2 and no less than 6 hours and no more than 72 hours for ER/PR.
• Type of processing, if other than routine (microwave tissue processing or rapid tissue processing), for paraffin blocks 

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Estrogen and progesterone receptor (ER/PR) detection is available by immunohistochemical staining and can have semi- quantification by Digital Image Analysis if requested. See General Test Listing of this Directory.

Submit a formalin-fixed, routinely processed paraffin-embedded tissue block, one (1) routinely stained (hematoxylin and eosin) histologic section from the block and 5 unstained freshly cut histologic sections on positively charged slides. Do not oven dry unstained slide(s) before sending out for testing. Avoid decalcifying procedures which may affect results. Avoid freezing or crushing artifacts. A histologic section of the submitted tissue block is evaluated by a pathologist to determine what may adversely affect ER/PR staining results.

Include a completed Test Requisition with appropriate clinical history and a copy of the original requisition and pathology report.

Indicate the following, as applicable, on the Test Requisition:

• Time and date of collection (comment if unknown)
• Cold ischemia time (time between removal and fixation)
• Type of fixative if other than formalin (comment if unknown) 
• Type of processing, if other than routine (microwave tissue processing or rapid tissue processing), for paraffin blocks and slides submitted for ER/PR and/or HER2. 

Wrap the blocks individually and transport in a cooled container/s with frozen gel ice packs/dry ice or ambient temperature to prevent the melting of paraffin-embedded tissue blocks from excessive heat during transit. Transport the slides at cool/ambient temperature.

DNA ploidy or cell cycle analysis determinations on paraffin-embedded tissues by both flow cytometry and digital image analysis are available.

HER2 ISH (FISH, CISH) testing is performed on paraffin-embedded tissue blocks. Send blocks that are properly fixed and processed. Include specimen site, type of fixation, time into fixation (if available), duration of fixation (if available) and type of tissue processing. Wrap the blocks individually and transport in a cooled container/s with frozen gel ice packs/dry ice or ambient temperature to prevent the melting of paraffin-embedded tissue blocks from excessive heat during transit. Transport the slides at cool/ambient temperature.

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Requests for grossing and preparation of stained slides to be returned without pathologist review must be arranged in advance by contractual agreement.

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Requests for pathologist primary diagnostic review (not a second opinion or consultative review) of slides prepared by the client’s histology laboratory must be arranged in advance by contractual agreement.

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The extent of tissue examination can be determined only during the pathologist’s examination of the specimen. The examination may require special studies, markers, or stains as deemed appropriate for proper evaluation by the Quest Diagnostics Pathologist; this includes ER/PR and Her2 for malignant breast biopsies. Additional HER2 testing must be attempted in equivocal specimens to attempt to obtain a positive or negative HER2 test result and most accurately determine the HER2 status of the tumor specimen. These additional tests will result in additional charges (see below).

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The fee for histopathology services will vary depending upon the number of specimens submitted, the size and complexity of the specimen and the necessity for additional tests. The fees and submission of bills to patients, customers, and health plans will be based on Current Procedural Terminology (CPT®) codes.

For questions, please contact your local Quest Diagnostics laboratory.

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