Posted April 4, 2013
Modification to CAP Checklist Requirement ANP.22999
Dear CAP Accreditation Participant:
The following modification to the note included in the Anatomic Pathology requirement, ANP.22999, is effective immediately.
|ANP.22999||HER2 by IHC – Scoring||Phase II|
| ||If the laboratory interprets HER2 protein over-expression by immunohistochemistry (IHC), results are reported using the ASCO/CAP scoring criteria.|
NOTE: The report should include the ASCO/CAP reference including the version number. For FDA-approved/cleared test systems, the manufacturer’s instructions should be followed. Laboratories using FDA-approved/cleared test systems should follow the interpretation criteria defined in the manufacturerâ€™s instructions, unless the laboratory has performed a validation study to allow for the use of the ASCO/CAP scoring criteria.
1. Wolff AC, Hammond ME, Schwartz JN, et al. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer. Arch Pathol Lab Med 2007;131:18-43.
The revision to ANP.22999 will be published in the 2013 checklist edition. The ASCO/CAP guideline recommends the use of specific scoring criteria for interpretation of HER2 protein over-expression by immunohistochemistry (IHC). The CAP recognizes that some FDA-approved or cleared test systems have obtained FDA approval using different scoring criteria, which are defined in the manufacturer’s instructions. Laboratories using FDA-approved/cleared test systems should follow the interpretation criteria defined in the manufacturer’s instructions, unless the laboratory has performed a validation study to allow for the use of the ASCO/CAP scoring criteria.
This change and other checklist errata can be found online via e-LAB Solutions™. Log in and select Laboratory Accreditation>LAP Resources for the Laboratories>Checklist Errata Documents.
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