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Cytology: Introduction

Both Gynecologic and Non-Gynecologic Cytology are available from all Quest Diagnostics laboratories. For Gynecologic Cytology (Pap tests) we provide liquid-based and conventional Pap collection kits with detailed collection and submission instructions. Our reports use standard descriptive Cytopathology terminology (Bethesda 2014), which includes feedback on sample adequacy and HPV results on the same report when ordered as a reflex or panel on the Test Requisition.

The Pap is a screening test for cervical cancer. It is not a diagnostic test and is subject to false negative and false positive results. It is most reliable when a satisfactory sample, regularly obtained, is submitted with relevant clinical findings and history, and when the Pap result is evaluated along with historic and current clinical information.

Testing for Human Papilloma Virus (HPV) is an important adjunct to the detection of premalignant or malignant lesions, and it can be performed on the same liquid medium used to submit Gynecologic Cytology samples. HPV testing can be optionally ordered as a reflex to Atypical Squamous Cells of Undetermined Significance (ASCUS) in women aged 21 and older, or in conjunction with the Pap in women aged 30 to 65. ASCCP Guidelines suggest that women aged 30 to 65 with a positive HPV and negative Pap be further evaluated for the presence of HPV Genotypes 16, 18 or other. Quest Diagnostics has modified and validated commercially available tests for HPV in order to perform these assays using the sample collected and submitted in a ThinPrep® or SurePath™ vial. Testing for N. gonorrhoeae (NG), C. trachomatis (CT), Herpes Simplex 1 & 2 and Trichomonas Vaginalis can also be performed on the same liquid medium used to submit cytology samples. Quest Diagnostics has modified and validated commercially available tests for CT and NG in order to perform these assays using the sample collected and submitted in a ThinPrep® or SurePath™ vial.

Quest Diagnostics offers computer-assisted Pap testing. Selecting this option when ordering a Pap test does not change the instructions provided below on Specimen Collection and Handling or on the availability of additional testing such as HPV and/or HPV Genotyping. In instances where computer-assisted imaging is unable to be performed, traditional manual screening will be performed.

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General Submission Requirements

Specimen Identification

We cannot accept specimens that are not properly labeled. Two forms of patient ID are required by the College of American Pathologists (CAP). Label primary* specimen container wall (not the lid) with two (2) 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.

Acceptable SECOND patient identifiers may be one (1) of the following:

  • Date of birth (month/day/year)
  • Other unique patient identifier, e.g., hospital or office ID code or file number
  • Quest Diagnostics requisition number or specimen barcode label provided on our requisition
  • Other barcode labels can be used if barcode matches the unique identifiers on the printed requisition

*Primary specimen container is the innermost container received by the laboratory.

  • Label all slides on frosted end in pencil with patient’s first initial and full last name and a second acceptable, unique positive patient identifier at the time of collection.
  • Label specimen containers (on the container wall, not the lid) with the patient’s first initial and full last name and/or unique identifier(s) and site(s) of specimen collected.

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Specimen Stability

  • ThinPrep vials with GYN specimen for Pap require transport at 15 °C to 30 °C.
  • ThinPrep vials with GYN specimen for Pap – refrigerated and frozen samples will be rejected.
  • ThinPrep vial stability – 42 days (6 weeks) from date of collection
  • SurePath vials with GYN specimen - 6 months at refrigerated temperatures
  • (2 °C to 10 °C) or up to 4 weeks (28 days) at room temperature (15 °C to 30 °C). 

Unacceptable Specimens

  • No patient identification on the Test Requisition
  • Illegible or no patient identification on the slide or specimen container. Labeling the slide holder only is not adequate identification.
  • No account/physician number or name on Test Requisition
  • Slides broken beyond repair
  • Leakage of sample during transport
  • Mismatch between name of patient on specimen and name on Test Requisition
  • No source indicated on Test Requisition for non- Gyn specimens
  • Expired liquid- based preservative/vial
  • SurePath™ Pap Test (blue vial) without either a combined brush/spatula or a broom collection device.
  • Syringes are not acceptable specimen containers.
  • Transport of needles violates Department of Transportation regulations.

Supplies

We strongly recommend the use of our collection materials (Cytopathology Test Requisition, liquid- based collection vials, slides, fixatives, endocervical brushes, brooms, spatulas, and slide containers).

GYNECOLOGIC CYTOLOGY SPECIMENS

The Pap Test

Ordering Information

Complete a Cytopathology Test Requisition including:

  • Patient’s full first and last name (any name change in the past 5 years should be noted) and unique identifier
  • Date of birth
  • Test ordered
  • Date of specimen collection
  • Source of specimen (cervical, endocervical, vaginal, or other gynecologic site)
  • Submitting physician’s name, UPIN or NPI number, and telephone number
  • Last Menstrual Period (LMP)
  • Menstrual status (hysterectomy, pregnant, postpartum, menopause, hormone therapy)
  • Previous abnormal cervical cytology results, previous treatment, biopsy, or surgical procedure
  • Other clinical information/history, as requested on a Cytopathology Test Requisition, as applicable

Guidelines for Medicare Pap Ordering

According to the Centers for Medicare and Medicaid Services (CMS), Papanicolaou (Pap) tests performed on Medicare beneficiaries are covered differently depending on the patients’ clinical history and timings and findings of their last Pap tests. Therefore, in order for Medicare beneficiaries to receive this benefit appropriately, Pap tests for Medicare beneficiaries must be ordered by providers and billed by laboratories according to the same criteria.

MLN006559 – Medicare Preventive Services (cms.gov)

For Medicare patients, the ordering guidelines are as follows:

Cytology Medicare Screen – Routine (covered once every 2 years) is for a routine screening Pap test for a patient with no current signs or symptoms or risk factors for developing cervical cancer.

Cytology Medicare Screen – High Risk (covered once every year) is for a patient with no current signs and symptoms but with risk factors for developing cervical cancer.

Cytology Medicare Medical Necessity (covered if supported by client-provided ICD codes) is for a patient with current signs and/or symptoms of possible cervical cancer.

A completed and signed Advance Beneficiary Notice (ABN) is required each time either screening test is ordered, due to possible non-coverage for excessive frequency. A completed and signed Advance Beneficiary Notice is required for the Medical Necessity Pap test when the accompanying ICD codes do not meet Medicare’s coverage criteria. Please refer to the Medicare medical necessity coverage guidelines provided by Quest Diagnostics.

Patient Preparation

  1. Schedule an appointment approximately two (2) weeks (10-18 days) after the first day of the last menstrual period. In the case of concurrent Pap and biopsy samples, the Pap sample should be taken before application of acetic acid or Lugol solution before biopsy. Menses may interfere with Pap test interpretation.
  2. No use of douche for 48 hours prior to the test.
  3. No use of tampons, birth control foams, jellies/lubricants or other vaginal creams or vaginal medications for 48 hours prior to the test.
  4. Refrain from intercourse 48 hours prior to the test.
  5. The clinician should not use any lubricant jelly for the examination until after the Pap has been obtained.
  6. Testing for Human Papilloma Virus (HPV) is an important adjunct to the diagnosis of pre-malignant or malignant lesions, and it can be performed on the same liquid medium used to submit cytology samples. Quest Diagnostics has modified and validated commercially available tests for HPV in order to perform these assays using the sample collected and submitted in a ThinPrep® or SurePath® vial.
  7. Testing for N gonorrhoeae (NG), C trachomatis (CT), Trichomonas vaginalis, and herpes simplex virus can also be performed on the same liquid medium used to submit cytology samples. Quest Diagnostics has modified and validated these commercially available tests in a ThinPrep® or SurePath® vial.
  8. Swabs for STIs are collected AFTER Pap.

Pap Specimen Collection and Handling

Liquid transport media are preferred for gynecological cytology specimens. Two such systems are available: the SurePath® Pap Test and the ThinPrep® Pap Test.

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SurePath™ Pap Test Specimen Collection and Handling

Brush/Spatula Device (PapPerfect® Spatula and Cytobrush® GT)

Contraindications: The Cytobrush® GT is not intended for use in pregnant women. For patients who are pregnant or do not have a cervix, follow Steps 1-4 and 7-8 only.

  1. Complete the Cyto/Tissue or Ob-Gyn requisition or order entry into your EMR system or Quanum.
  2. Record the patient’s First Initial and Full Last Name and unique identifier(s) on the vial.
  3. Select contoured end of PapPerfect® plastic spatula and rotate 360° around the entire ectocervix while maintaining tight contact with exocervical surface.
  4. Visually locate the notched score line on the side of the spatula handle, about 4 cm from the contoured collection end. With gloved hand(s) and one (1) single, quick, and firm SNAP, separate the contoured end from the rest of the spatula handle. Do not touch collection end. Drop this contoured collection end into a vial of SurePath™ preservative labeled with the patient’s name. Discard remaining device handle end of the spatula after each use. Place cap on vial until Step 6; do not tighten cap. For patients who are pregnant or do not have a cervix, proceed to Steps 7-8.
  5. Obtain an adequate sampling from the endocervix using an endocervical brush device. Insert Cytobrush Plus® GT device into the endocervix until only the bottom-most bristles are exposed at the os. Slowly rotate ¼-½ turn in one (1) direction. To reduce unnecessary bleeding, do not over-rotate brush. DO NOT ROTATE BRUSH MORE THAN ½ TURN. Over-rotation may result in poor sample collection. Remove Cytobrush® device.
  6. Visually locate the notched score line on the side of the Cytobrush® handle, about 4 cm from the brush tip. With gloved hand(s) and one (1) single, quick, and firm SNAP, separate the brush head-short handle from the rest of the brush handle. Do not touch collection end. Drop brush head-short handle into the same vial of SurePath™ preservative. Discard remaining device handle end of Cytobrush®.
  7. Tighten the SurePath™ vial cap so the torque line on the cap passes the torque line on the vial.
  8. Place the vial and requisition in a specimen bag for transport to the laboratory at room temperature.

Broom-Like Device (Rovers® Cervex-Brush®)

Contraindications: The Rovers® Cervex-Brush® should not be used after the first 10 weeks of gestation in pregnant women. For patients who are past 10 weeks gestation or do not have a cervix, refer to the Spatula Device instructions above (Steps 1-4 and 7-8).

  1. Complete the Cyto/Tissue or Ob-Gyn requisition or order entry into your EMR system or Quanum.
  2. Record the patient’s first initial and full last name and/or unique identifier(s) on the vial.
  3. Obtain an adequate sampling from the cervix using a broom-like device.
  4. 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 (5) times. DO NOT ROTATE IN A COUNTERCLOCKWISE DIRECTION.
  5. Remove and “pop off” broom head into a vial of SurePath™ preservative labeled with the patient’s first initial and full last name and unique identifier(s) on the vial.
  6. Tighten the cap so the torque line on the cap passes the torque line on the vial.
  7. Place the vial and requisition in a specimen bag for transport to the laboratory at room temperature.

Broom-Like Device (Rovers® Cervex-Brush® Combi)

Contraindications: The Rovers® Cervex-Brush® should not be used after the first 10 weeks of gestation in pregnant women. For patients who are past 10 weeks gestation or do not have a cervix, refer to the Spatula Device instructions above (Steps 1-4 and 7-8).

  1. Complete the Cyto/Tissue or Ob-Gyn requisition.
  2. Record the patient’s first initial and full last name and/or unique identifier(s) on the vial.
  3. Insert the central bristles of the brush into the endocervical canal. Use gentle pressure on the cervix until the lateral bristles bend against the ectocervix.
  4. Maintain the gentle pressure and rotate the Rovers® Cervex-Brush® Combi two (2) times in a clockwise direction by rolling the stem between the thumb and forefinger.
  5. Remove and “pop off” broom head into a vial of SurePath™ preservative labeled with the patient’s first initial and full last name and unique identifier(s) on the vial.
  6. Tighten the cap so the torque line on the cap passes the torque line on the vial.
  7. Place the vial and requisition in a specimen bag for transport to the laboratory at room temperature.

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ThinPrep® Pap Test™ Specimen Collection and Handling

Brush/Spatula Device

Contraindications: The Cytobrush® GT is not intended for use in pregnant women. For patients who are pregnant or do not have a cervix, follow Steps 1-4 and 7-8 only.

  1. Complete the Cyto/Tissue or Ob-Gyn requisition or order entry into your EMR system or Quanum.
  2. Record the patient’s first initial and full last name and/or unique identifier(s) on the vial.
  3. Select contoured end of Pap Perfect® plastic spatula and rotate 360° around the entire endocervix while maintaining tight contact with the exocervical surface.
  4. Immediately rinse the spatula in the PreservCyt® Solution vial by swirling vigorously in the vial 10 times. Discard the spatula. Do not let the spatula sit in the vial.
  5. Obtain an adequate sampling from the endocervix using an endocervical brush device. Insert the brush into the endocervix until only the bottom-most bristles are exposed at the os. Slowly rotate ¼-½ turn in 1 direction. To reduce unnecessary bleeding, do not over-rotate brush. DO NOT ROTATE BRUSH MORE THAN ½ TURN. Over-rotation may result in poor sample collection.
  6. Rinse the brush in the PreservCyt® Solution by rotating the device in the solution 10 times while pushing against the PreservCyt® vial wall. Swirl the brush vigorously to further release material. If material is still visible on the bristles, then scrape the bristles with the spatula staying within the fluid. Swirl the brush vigorously to further release material. Do not let the brush sit in the vial. Do not break off the collection device in the vial.
  7. Discard the brush.
  8. Tighten the cap so the torque line on the cap passes the torque line on the vial.
  9. Place the vial and requisition in a specimen bag for transport to the laboratory at room temperature.

Broom-Like Device (Rovers® Cervex-Brush®)

Contraindications: The Rovers® Cervex-Brush® should not be used after the first 10 weeks of gestation in pregnant women. For patients who are past 10 weeks gestation or do not have a cervix, refer to the Spatula Device instructions above (Steps 1-4 and 7-8).

  1. Complete the Cyto/Tissue or Ob-Gyn requisition or order entry into your EMR system or Quanum.
  2. Record the patient’s first initial and full last name and/or unique identifier(s) on the vial.
  3. Obtain an adequate sampling from the cervix using a broom-like device. 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 (5) times.
  4. Rinse the broom in the PreservCyt® Solution vial by pushing the broom into the bottom of the vial ten (10) times, forcing the bristles apart. Swirl the broom vigorously to further release material. If material is still visible on the bristles, then scrape the bristles against the vial staying within the fluid. Swirl the broom vigorously to further release material. 
  5. Discard the collection device.
  6. Tighten the cap so the torque line on the cap passes the torque line on the vial.
  7. Place the vial and requisition in a specimen bag for transport to the laboratory at room temperature.

Broom-Like Device (Rovers® Cervex-Brush® Combi)

Contraindications: The Rovers® Cervex-Brush® Combi should not be used during pregnancy. For patients who are past 10 weeks gestation or do not have a cervix, refer to the Spatula Device instructions above (Steps 1-4 and 7-8).

  1. Complete the Cyto/Tissue or Ob-Gyn requisition or order entry into your EMR system or Quanum.
  2. Record the patient’s first initial and full last name and/or unique identifier(s) on the vial.
  3. Insert the central bristles of the brush into the endocervical canal. Use gentle pressure on the cervix until the lateral bristles bend against the ectocervix.
  4. Maintain the gentle pressure and rotate the Rovers® Cervex-Brush® Combi two (2) times in a clockwise direction by rolling the stem between the thumb and forefinger.
  5. Rinse the broom in the PreservCyt® Solution vial by pushing the broom into the bottom of the vial 10 times, forcing the bristles apart. Swirl the broom vigorously to further release material. If material is still visible on the bristles, then scrape the bristles against the vial staying within the fluid. Swirl the broom vigorously to further release material. Do not let the broom sit in the vial. Do not break off the collection device in the vial.  
  6. Discard the collection device. 
  7. Tighten the cap so the torque line on the cap passes the torque line on the vial.
  8. Place the vial and requisition in a specimen bag for transport to the laboratory at room temperature.

Conventional Pap Test Specimen Collection and Handling

  1. Complete the test requisition or order entry into your EMR system or Quanum.
  2. Using a lead pencil, write the patient’s first initial and full last name and/or unique identifier(s) on the frosted end of the slide. Unlabeled slides cannot be accepted.
  3. Insert the extended tip of the spatula in the endocervical canal and rotate allowing blunt edge of spatula to scrape the ectocervix. Do not smear yet. For patients who do not have a cervix: Use the blunt end of the spatula to scrape the vaginal wall(s). Proceed to Step 5.
  4. Insert the Cytobrush® into the endocervical canal until the bristles are barely visible. Turn 90°-180° and remove. Brush is not recommended for use during pregnancy.
  5. Smear the extended tip spatula (cervical) specimen and/or blunt-ended spatula (vaginal) specimen along the entire length of the slide using only half of the surface.
  6. Roll the Cytobrush® (endocervical) specimen along the entire length of the slide using the remaining half of the slide surface. Bending the bristles will help transfer the cells to the slide.
  7. Immediately apply fixative. If using spray fixative, hold the dispenser 6-10” from the slide. DO NOT use commercial hair spray as a fixative. The variability of ingredients results in poor specimen preservation.
  8. Allow to dry completely before closing the slide holder.

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NON-GYNECOLOGICAL CYTOLOGY SPECIMENS

Ordering Information

Complete a Cytopathology Test Requisition including:

  • Patient’s full first and last name (any name change in the past 5 years should be noted), and unique identifier.
  • Date of birth
  • Submitting physician’s name, UPIN or NPI number, and telephone number and account information.
  • Source and specific anatomic site (e.g., body site, left, right, quadrant, etc)
  • Date of specimen collection
  • Collection method (e.g., washing, brushing, FNA, fluid, etc)
  • Nature of lesion (e.g., solid/cystic, mobile/fixed, functional/nonfunctional, etc)
  • Any other pertinent history (e.g., previous surgery, presence of other masses, previous abnormal findings)
  • Mammography, X-ray, or other imaging findings
  • Diagrams of the site sampled may be helpful, especially for fine needle aspiration biopsies
  • Record the length of time in fixative and the cold ischemia time for predictive Immunocytochemical studies, if applicable

Please provide the below information, as outlined in the College of American Pathologists, regulatory requirement, CYP.04510 (see below), when ordering immunocytochemical tests on non-gynecological cytology and/or fine needle biopsy specimens.

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Specimen Collection and Handling

Smear

(NOTE: Cyst contents should be submitted as fluids and not smears.)

  1. Write the patient’s first initial and full last name and an acceptable unique positive identifier in pencil on the frosted end of slide.
  2. Submit 1-5 slide(s) of material from any source that can be evaluated cytologically.
  3. Place residual specimen into a CytoLyt fixative vial
  4. Allow the fixative to dry thoroughly before packaging slides for transport.
  5. Submit in an appropriate slide container at room temperature.

Fluid/Washings

  • Submit the fluid fixed with a minimum of 10 mL of fixative. 
  • Specimens larger than 10 mL should be fixed with an equal volume of fixative. 
  • Preferred is the CytoLyt® collection vial.

Appropriate Fixatives for Non-Gyn Cytology Specimens

If you have any questions, please contact local Quest Diagnostics Cytology department for assistance in selecting the preferred non-Gyn fixative for patient samples.

Fixed Specimens - Refrigerated or room temperature; Do NOT freeze.

Unfixed Specimens - Refrigerated or room temperature; Do NOT freeze.

Acceptable Fixatives:

• CytoLyt® Solution (preferred fixative for most non-Gyn specimens)

• Ethyl alcohol

• Isopropyl or methyl alcohol may be used as a substitute if neither of the above 2 fixatives is available.

The following collection solutions are not recommended with the ThinPrep® System:

• Saccomanno and other solutions containing a carbowax

• Alcohols

• Mucollexx

• Normal Saline

• Phosphate Buffered Saline (PBS)

• Culture media

• RPMI solution

• Solutions containing formalin

 

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CytoRich®  

CytoRich® Red* (SurePath™ processed specimens only)

  • Solubilizes protein and lyses red blood cells 
  • Excellent for fine needle aspirations 
  • General non-Gyn and endometrial cell preservation 
  • Extended sample stability 

CytoRich® Blue (SurePath™ processed specimens only) 

  • General Purpose Cell Preservative 
  • Excellent for urine and non-hemolytic samples 
  • Recommended for use as a general cytology preservative 
  • Excellent for fine needle aspirations 
  • General non-Gyn and endometrial cell preservation 
  • Extended sample stability 

Place fluid/fixative mixture in a tightly capped, leak- proof, labeled container (label the container wall, not the lid).

The following specimens are prepared by mixing the material with an equal volume of fixative:

  • Breast Cyst Aspiration
  • Effusion (Ascites, peritoneal or pericardial fluid)
  • Bronchial Washings/Lavages
  • Endometrial Washings
  • Esophageal Washings
  • Gastric Washings
  • Paracentesis (Abdominal) Fluid/Ascites
  • Pericardial Fluid
  • Thoracentesis (Pleural or chest) Fluid
  • Urine Brushing

Non-Gynecological Cytology Specimen Types

Brushings 

Roll brush(es) over clean, dry slide(s). Fix immediately with alcohol or spray fixative. The brush(es) used to prepare the slides may be submitted in the CytoLyt® fixative container and/or swirled in a container of appropriate fixative to dislodge additional specimen. 

Submit slides and liquid specimen together with one (1) Test Requisition.

Breast Secretion (Nipple Discharge)

Smear drops of fluid from the nipple directly onto clean glass slides and fix immediately with spray fixative or immerse in alcohol for 3–5 minutes.

Lymph Node (Touch Prep) 

Label one (1) “ air-dried” slide. Fix remaining slide(s) immediately in alcohol or use spray fixative. 

Lymph Node Aspirate for Flow Cytometry  

Place aspirated Non-Gyn material into 15 mL tube containing RPMI-based, or other tissue culture, or cytogenetics medium. 

Ship at room temperature within 48 hours (can be transported refrigerated). 

Use only RPMI-based or other tissue culture or cytogenetics medium. DO NOT use any fixative (formalin, alcohol, etc) or saline.

Skin (Viral) Lesion: Tzanck Smear 

Remove crust or dome from lesion. Scrape ulceration with a curette. Spread material on alcohol- moistened slide. 

Fix slides immediately (within a few seconds) using cytology spray fixative or immerse in alcohol fixative for 3–5 minutes. 

Sputum 

Submit early-morning deep- cough specimen prior to any food ingestion. Have patient rinse mouth with plain water before sputum is collected. 

Collect separate specimens on 3 consecutive mornings. Do not pool the specimens. Mix material with an equal volume of fixative.

Anal Non-Gyn Cytology (ThinPrep collection preferred)

To obtain an anal cytology sample:

  1. Moisten the polyester-tipped applicator (not cotton) swab with water. Do not use lubricant.
  2. The polyester-tipped applicator swab should be inserted approximately 1.5 to 2 inches into anal canal. It is important to use polyester-tipped applicator and not a cotton swab as cells tend to cling.
  3. Rinse the swab in the PreservCyt® Solution vial by pushing the broom into the bottom of the vial 10 times, forcing the bristles apart. Swirl the swab vigorously to further release material. If material is still visible on the swab, then scrape the swab against the vial staying within the fluid. Swirl the swab vigorously to further release material. Discard the collection device. Do not let the swab sit in the vial. 
  4. Tighten the cap so the torque line on the cap passes the torque line on the vial.
  5. Place the vial and requisition in a specimen bag for transport to the laboratory at room temperature.

Urine

Instructions for Urine Collected in the Office (Voided or Catheterized) 

Submit all specimens in an equal volume of fixative (See Appropriate Fixatives for Non- Gyn Cytology Specimens in the Cytology section). Mark Test Requisition “Voided” or “Catheterized” as applicable. For offices with centrifugation capability, see steps 2 and 3 in the Urine Collected When a Centrifuge Is Available category below. 

Please note, urine specimen may be submitted without Fixatives. First morning voided urine without Fixative is preferred specimen for non-gyn cytology with reflex FISH testing.

Patient Instructions for Urine Collected at Home 

  1. Provide patient with an appropriate volume of fixative (e.g., 50 mL of ethyl alcohol or pre- measured container of CytoLyt®). 
  2. Instruct the patient to drink three (3) 8-oz. glasses of water before bedtime. 
  3. Instruct the patient to discard the first morning void and collect the specimen from the second morning void. Mix an equal volume with the fixative. Do not submit a 24-hour urine collection for cytologic evaluation. 

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Report Elements Phase II

For immunocytochemical tests that provide independent predictive information, the patient report includes information on specimen processing, the antibody clone, and the scoring method used.

NOTE: The laboratory processing the cytology specimen must record the cold ischemia time (if applicable) and the length of time in fixative. If the cytopathology laboratory refers immunocytochemistry or ISH studies, this information must be provided to the laboratory(ies) performing these studies.

For immunocytochemical studies used to provide predictive information independent of diagnosis or other cytopathologic findings (eg, hormone receptors and HER2 in breast carcinoma, PD-L1 and lung adenocarcinoma predictive immunostains), the laboratory must include the following information in the patient report:

  • The type of specimen fixation and processing (eg, formalin-fixed paraffin-embedded sections, air-dried imprints, etc.)
  • The antibody clone and general form of detection system used (eg, LSAB, polymer, proprietary kit, vendor name, etc.; information on the type of equipment used is not necessary).
  • Criteria used to determine a positive vs. negative result, and/or scoring system (eg, percent of stained cells, staining pattern)
  • Laboratory interpretation of predictive marker testing is reported according to the manufacturer's instructions, or when available, following the structure, format, and criteria set forth in the current CAP guidelines relating to predictive marker testing (eg, ASCO/CAP HER2 and ER testing in breast cancer and CAP/ASCP/ASCO HER2 in gastroesophageal carcinoma)
  • Limitations relating to suboptimal preanalytical factors that may impact results, such as prolonged cold ischemia time, unknown ischemia time, or over- or under-fixation.

 

Evidence of Compliance:

  • Report template containing all required elements AND
  • Copies of patient reports confirming inclusion of the required elements AND
  • Established guidelines used by the laboratory

 

REFERENCES

  1. Fischer AH, Schwartz MR, Moriarty AT, et al. Immunohistochemistry practices of cytopathology laboratories: a survey of participants in the College of American pathologists Nongynecologic Cytopathology Education Program. Arch Pathol Lab Med. 2014;138(9):1167-72.
  2. Fisher ER, et al. Solving the dilemma of the immunohistochemical and other methods used for scoring ER and PR receptors in patients with invasive breast cancer. Cancer. 2005;103:164-73 
  3. Collins LC, et al. Bimodal frequency distribution of estrogen receptor immunohistochemical staining results in breast cancer: an analysis of 825 cases. Am J Clin Pathol. 2005;123:16-20 
  4. Allred DC, et al. ER expression is not bimodal in breast cancer. Am J Clin Pathol. 2005;124:474-5 
  5. Wolff AC, Somerfield MR, Dowsett M, et al. Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer: American Society of Clinical Oncology/College of American Pathologists Guideline Update. Arch Pathol Lab Med. Published online June 7, 2023. doi: 10.5858/arpa.2023-0905-SA.
  6. Allison KH, Hammond EH, Dowsett M, et al. Estrogen and Progesterone Receptor Testing in Breast Cancer: American Society of Clinical Oncology/College of American Pathologists Guideline Update Arch Pathol Lab Med. 2020; 144(5):545-63.
  7. Bartley AN, Washington MK, Ventura CB, et al. HER2 Testing and Clinical Decision Making in Gastroesophageal Adenocarcinoma: Guideline from the College of American Pathologists, American Society for Clinical Pathology, and American Society of Clinical Oncology. Arch Pathol Lab Med. 2016:140(12):1345-1363.

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