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«Frequently Asked Questions Recommendations for HER2 Testing in Breast Cancer: ASCO – CAP Clinical Practice Guideline Update Background Questions ...»

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HER2 by Brightfield in situ Hybridization Survey (ISH2) The ISH2 Survey is a CISH (chromogenic in situ hybridization) and SISH (silver in situ hybridization) Survey that provides 10 challenges, twice a year. Enrollment in the ISH2 Survey will satisfy alternative assessment requirements for ISH.

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What PT does the CAP Laboratory Accreditation Program require?

At this time, CAP is the only accepted PT provider for HER2, ER and PgR.

We report HER2, ER and PgR using an automated image analysis system. What requirements apply to us?

Image analysis can be an effective tool for improving interpretation consistency; however, the pathologist is responsible for ensuring that the result provided by image analysis reflects measurement of invasive carcinoma only. The pathologist must document that he or she has reviewed either the stained patient test slides or the images and ensured that the appropriate area was scored.

Image analysis equipment, just as other laboratory equipment, must be calibrated and subjected to regular maintenance and internal quality control evaluation. Image analysis procedures must be validated before implementation. See the CAP guideline, Validating Whole Slide Imaging for Diagnostic Purposes in Pathology for more information.

Laboratories that do HER2 or ER/PgR staining by IHC and use in-house image analysis for interpretation and reporting are required to enroll in an IHC-based PT program and report the results following the usual testing and reporting methods used.

Laboratories that interpret and report the results of HER2 or ER/PgR testing by IHC in which staining and image analysis are performed at an outside laboratory are required to enroll in PT but must ensure that they only receive back the stained PT slide or an image of the stained PT slide. The laboratory must ensure that the outside laboratory does not send back any quantitative image analysis data as that would constitute PT Referral by CMS which can have serious consequences. As noted above, image analysis is a useful tool, but pathologists should also be able to manually score the slide without the use of quantitative image analysis.

All labs participating in PT must provide results for all PT challenges regardless of specific methods of testing used. If the PT program includes manual scoring of virtual slides or images (in addition to actual tissue challenges), every lab must provide manual scoring results for these challenges even if they normally only interpret glass slides or report results by quantitative image analysis.

We do not do IHC staining, but interpret and report HER2 and ER/PgR slides that are stained by an outside facility. Are we still required to enroll in PT?

Yes. Laboratories that interpret HER2, ER, or PgR slides stained by another facility must enroll in a CAP-accepted PT program and report the results of their interpretation. Since CAP is currently the only accepted HER2/ER/PgR PT provider, such labs must enroll in CAP’s HER2 and/or PM2 Surveys. You must send the unstained Survey slides to the outside facility for immunohistochemical staining, and report the results of your interpretation of the stained slides.

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Yes. All laboratories that perform and/or interpret HER2 or ER/PgR testing are required to enroll in a CAP-accepted PT program (see exception below). Laboratories that send materials to another facility for staining by IHC and image analysis are required to enroll in an appropriate IHC-based PT program. For the tissue challenges in the HER2 and PM2 Surveys, the laboratory should send the slides to the outside facility for staining only; do not request quantitative image analysis at the outside facility even if this is routinely done for patient testing. Doing so could be considered PT Referral and result in severe sanctions by CMS. You must report the results of manual scoring for these PT slides. The PT Referral prohibition does not apply to staining and image analysis that are both performed in house.

Exception: Laboratories that do such testing only on tissues other than primary breast cancers (e.g. other tumor types such as meningioma; for lineage determination only) are not required to enroll in proficiency testing that is specific for those analytes. Laboratories that send all primary breast cancers to another facility for both staining and interpretation are not required to enroll in PT.

In the CAP’s HER2 and PM2 Programs, all results of PT challenges are reported using manual scoring. There is currently no separate reporting by quantitative image analysis. All laboratories must provide results using the scoring systems outlined in the PT kit instructions and stained tissue challenges, even those that normally report results using a quantitative image analysis system provided by an outside laboratory.

Our HER2 and ER/PgR cases are sent to an outside laboratory for testing and interpretation, but we include their results in our pathology reports. Are we required to enroll in PT?

No. Proficiency testing only applies to laboratories that perform and/or interpret the assays, not to those that simply report the results that are performed and interpreted by an outside laboratory. Labs must enroll in PT if they provide a professional interpretation, even if they are using an outside laboratory for staining and/or image analysis.

Is the laboratory required to submit results from each pathologist during every PT event?

Only the results of the laboratory are reported to the PT provider. The laboratory is not required to provide responses from each pathologist for every PT challenge; however, these challenges must be integrated into the routine laboratory workload and analyzed using the same personnel and systems as for patient samples. Thus, if multiple pathologists routinely report HER2 or ER/PgR results in your lab, PT challenges must be done by a rotation that allows all pathologists to participate in scoring these challenges.

What are the new requirements for ongoing competency assessment for pathologists?

Pathologists should perform ongoing competency assessment as a part of every laboratory’s internal quality assessment program. The competency of the laboratory professionals and pathologists interpreting assays must be continuously addressed as required under CLIA (for US laboratories).

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