Posted April 30, 2013
Dear CAP Accreditation Participant:
The CAP has further revised the checklist requirement ANP.22999 based on your feedback in response to the recent alert sent on February 15, 2013. The revised requirement allows for the reporting of results using either the manufacturer’s instructions or the ASCO/CAP scoring criteria. The revision below is effective immediately and will be published in the 2013 Anatomic Pathology checklist.
|ANP.22999||HER2 by IHC – Scoring||Phase II|
| ||If the laboratory interprets HER2 protein over-expression by immunohistochemistry (IHC), results are reported using either the manufacturer’s instructions or the ASCO/CAP scoring criteria.|
NOTE: If the ASCO/CAP scoring criteria are used, the report includes the ASCO/CAP reference with the version number (e.g. year of publication).
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.
If the checklist revision impacts your laboratory, please retain a copy of this eAlert as a resource for any upcoming inspections.
View Frequently Asked Questions about this requirement. This change and other checklist errata can be found online via e-LAB Solutions™. Log in and select Laboratory Accreditation > LAP Resources for Laboratories > Checklist Errata Documents.
As a service to CAP Accredited laboratories, the CAP offers compliance alerts to help your laboratory maintain continuous compliance.
Thank you for your commitment to patient safety.
Questions? Contact us at 800-323-4040 or by email.