Digital Pathology and CAP Guidelines

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1 Digital Pathology and CAP Guidelines Frequently asked questions The VENTANA family of digital pathology products empowers you with the convenience of a comprehensive image and workflow solution. When used together, our integrated staining platforms, assays, scanners, algorithms, and workflow management solutions optimize your process for increased workflow efficiency and enhanced medical value. The College of American Pathologists (CAP) is dedicated to promoting the appropriate use of digital pathology equipment in laboratories worldwide. The CAP guidelines regarding digital image analysis provide a checklist for laboratories to maintain consistent results in every step of their workflow solution. The following guidelines are intended to help answer frequently asked questions about CAP guidelines and image analysis. Please note that the guidelines are updated yearly by CAP, and may change without notice. CAP Guidelines for Digital Image Analysis Definition: Digital image analysis is the computer-assisted detection or quantification of specific features in an image following enhancement and processing of that image, including IHC, DNA analysis, morphometric analysis and FISH Copyright Ventana Medical Systems, Inc. For Ventana & Roche use only. Do not copy.

2 Validation and Calibration ANP Preanalytic Documentation There is documentation that the preanalytic phase of the test system has been validated for each assay, including definition of acceptable specimen preservation, fixation and processing, and definition of how microscopic fields are selected for analysis. Note: test results may be affected by fixation parameters including time of fixation and the type of fixative used, and by hemorrhage, necrosis, and autolysis of tissue. This is the responsibility of the laboratory. Each laboratory should have written procedures on how the preanalytic phase of the test system has been validated with regard to specimen preservation, fixation, processing, etc. Each laboratory team should also document how they expect their pathologists to select fields for analysis (pathologists are already doing so under a microscope). Ventana recommends that pathologists select the number of fields they believe are representative of the tumor. Ventana does not give a recommendation on the number of fields as it is left to the judgment of the pathologist. In practice, many labs select 1-4 fields, depending on the specimen. ANP Appropriate slides are used for calibration Note: there are 2 types of image analysis systems currently in use in anatomic pathology. The first evaluates pixels without regard for pixel location (e.g. nucleus, cytoplasm, extracellular areas, etc.). The 2nd initially identifies objects (the nucleus, for example) in an image, then classifies the object as positive or negative. For pixel-based systems, calibration is accomplished by use of a slide that includes all of the possible intensity values that a pixel can occupy; this slide is then run for verification of calibration. For some systems, the vendor provides the calibration slide and calibration must be verified before a patient sample can be analyzed. For object-based systems, calibration must address two processes: 1) capturing or ignoring objects as appropriate, and 2) correct classification of captured objects, with establishment of the minimum threshold for scoring an object as positive. Typically, calibration slides are used to adjust for object detection based on minimum or maximum size, shape, etc. Next, the minimal staining threshold is established for classifying an object as positive, by comparing to background staining and counter staining for each run of patient specimens. A weakly expressed antigen should be used to establish the threshold (e.g. secretory endometrium for estrogen receptor). The calibration of the imaging system may be confined to the type of analysis e.g. nuclear, membrane or cytoplasm, etc. Calibration should include adjustment of light output, if applicable, to ensure that output is matched to the sensor s dynamic range. (This requirement does not apply to systems that feature internal calibration. The Quality Control requirements below, however, do apply.) It is the responsibility of the laboratory to validate the performance of the scanner in their lab environment. Each laboratory should have internal guidelines on specimen processing, fixation, equipment validation etc. The iscan Coreo and VENTANA iscan HT slide scanners are calibrated by Ventana personnel at installation, and this calibration is checked during the planned maintenance visits. For a daily or weekly calibration check, Ventana suggests scanning of the same 2-3 slides (FFPE tissues, IHC or H&E) and performing a visual inspection of the resulting images to ensure acceptable image quality. It is recommended that this activity be documented by the laboratory. The image analysis algorithm calibrations are done by Ventana, using the entire system including antibodies, detection reagents, stainer, software and slide scanner. Once calibrated, the algorithms are locked down, meaning the user cannot change any parameters within the algorithm. Once these calibrated algorithms are delivered to the lab, the lab also has the responsibility to validate the algorithm in their lab with their images. This can usually be done by comparing algorithm results to manual microscopic results on a series of slides with varying levels of expression. For suggestions on cases needed for validation, please refer to the CAP recommendations for assay validation. 2 Copyright Ventana Medical Systems, Inc. For Ventana & Roche use only. Do not copy. 2 12/4/ :04:36 AM

3 Quality Control Controls are samples that act as surrogates for patient/client specimens. They are periodically processed like a patient/client sample to monitor the ongoing performance of the analytic process. ANP Daily QC Control materials at more than one expression (level) are run concurrently with patient specimens. NOTE: controls should verify test performance at relevant decision points. For many tests, a positive and a negative control are sufficient. Controls need be run only on days when patient specimens are tested. For immunohistochemistry, the laboratory team must follow the control requirements in the Immunohistochemistry section of the Anatomic Pathology checklist. This is the responsibility of the laboratory. Each laboratory team should have written procedures on when to run controls, and what types of controls to run. The laboratory must also document and maintain QC results. For IHC, the laboratory also needs to comply with CAP guidelines specific to IHC. ANDP QC handling Control specimens are tested in the same manner and by the same personnel as patient/client samples. NOTE: QC specimens must be analyzed by personnel who routinely perform patient/client testing. This does not imply that each operator must perform QC daily, so long as each instrument and/or test system has QC performed at required frequencies, and all analysts participate in QC on a regular basis. To the extent possible, all steps of the testing process must be controlled, recognizing that pre-analytic and post-analytic variables may differ from those encountered with patient/clients. It is the responsibility of the laboratory to document and maintain records that the same personnnel are running both the control material as well as patient/client samples. ANP Positive threshold level A negative control is used to ensure that non-staining areas are scored as negative. Note: the negative control may be a separate slide or an area on the patient test slide that is known to be negative. This is the responsibility of the laboratory. Each laboratory team should follow CAP guidelines for negative controls. There should be a written laboratory policy defining positive staining. ANDP QC verification The results of control are verified for acceptability before reporting results. Note: control results must be reviewed before reporting patient/client results. It is implicit in quality control that patient/client test results will not be reported when controls do not yield acceptable results. It is the responsibility of the laboratory to review control results prior to reporting patient/client results. Additionally, the laboratory must maintain evidence of corrective action(s) when QC results are not acceptable. ANP Monthly QC review Quality control data are reviewed and assessed at least monthly by the lab director or designee. Note: the QC data for tests performed less frequently than once per month should be reviewed when tests are performed. It is the responsibility of the laboratory to maintain records of QC review with documented follow up for outliers, trends, and omissions. Each laboratory should follow CAP guidelines for quality control reviews /4/ :04:36 AM

4 Specimen Analysis ANDP QC Area of analysis A qualified pathologist selects the appropriate areas for analysis. It is the responsibility of the laboratory to ensure that a qualified pathologist interprets the test. This is similar to ensuring a qualified pathologist is reviewing a slide under a microscope. ANDP Analysis guidelines There are documented guidelines for identification of appropriate areas and cells for analysis. Note: evaluation of heterogeneous cell populations requires the use of specific guidelines and procedures, particularly if there is background or nonspecific staining, or if there is cell debris, endogenous pigment, and/or artifacts of aging, sectioning or preparation. It is the responsibility of the laboratory team to document guidelines on identification of areas and cells for analysis. Ventana does provide the following recommendations when selecting areas for analysis: avoid out of focus areas, avoid selecting areas with tissue folds, ink or debris. It is the responsibility of the pathologist to select tumor areas. Avoid selecting large areas of non-tumor (e.g., stroma, lymphocytes, necrotic areas) by making use of the various annotation tools provided in the software. 4 Copyright Ventana Medical Systems, Inc. For Ventana & Roche use only. Do not copy. 4 12/4/ :04:36 AM

5 Reports ANP Final Report Interpretation The final report includes an interpretation by the responsible pathologist. NOTE: Interpretation requires correlation with the light microscopic features such as routine histology,immunohistochemistry, cytologic material, cytogenetic and molecular studies, and/or clinical information. The Virtuoso software supports reporting of results including the final interpretation. If the Virtuoso software has been integrated with the laboratory s LIS, the results may also be sent to the LIS for report generation. ANP Final Report Elements The final report includes the criteria for positive and negative results including reference range. NOTE: The reference range may be determined by the laboratory s validation of the test system, or through evaluation of manufacturer s or other published information. The reference range is displayed on all reports generated in the Virtuoso software. ANP Final Report Elements The final report includes the specimen source, name of the vendor and imaging system used, the antibody clone or probe, and the detection method, as well as any limitations of the test result, if applicable. NOTE: For DNA staining, the CV (coefficient of variation) should be included in the patient report. The Virtuoso software is able to generate reports that allow for this information to be displayed /4/ :04:36 AM

6 Personnel ANP Imaging operator qualifications Personnel who operate the imaging system are qualified as high-complexity testing personnel under CLIA. It is the responsibility of the laboratory to ensure that qualified personnel operate the imaging equipment. ANDP Personnel-technical operations The person in charge of technical operations is qualified to perform high-complexity testing under CLIA, with at least one year s experience in image analysis under a qualified lab director. It is the responsibility of the laboratory to ensure that qualified personnel operate the imaging equipment. 6 Copyright Ventana Medical Systems, Inc. For Ventana & Roche use only. Do not copy. 6 12/4/ :04:36 AM

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8 Roche Diagnostics (Schweiz) AG Industriestrasse 7 CH-6343 Rotkreuz Switzerland Tel: +41 (0) Fax: +41 (0) Ventana Medical Systems, Inc. VENTANA, VENTANA logo, ISCAN and VIRTUOSO are trademarks of Roche. All other trademarks are the property of their respective owners. N A VENTANA Empowering Innovation 8 12/4/ :04:36 AM

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