[Histonet] CAP ANP.22970 Query

Cartun, Richard Richard.Cartun at hhchealth.org
Tue Aug 23 14:36:40 CDT 2016

Do you participate in the CAP's PT program for ER/PR and HER2 IHC testing?  If so, you can have all your pathologists who interpret ER/PR/HER2 IHC testing score the PT TMAs, complete the worksheets, and then you can establish their interobserver variability.  If not, pull 20 cases where ER/PR/HER2 was performed, prepare a score-sheet and have all your pathologists interpret these 20 cases.  Run the same comparison.  You will see ER positivity in the range of 75-90%, PR positivity in the range of 60-75%, and HER2 should be between 10-20%.  Obviously, these ranges will depend on your patient demographics, and the antibody clones and IHC detection used.


Richard W. Cartun, MS, PhD
Director, Histology & The Martin M. Berman, MD Immunopathology & Morphologic Proteomics Laboratory
Director, Biospecimen Collection Programs
Assistant Director, Anatomic Pathology
Hartford Hospital
80 Seymour Street
Hartford, CT  06102
(860) 972-1596
(860) 545-2204 Fax

-----Original Message-----
From: Joanne Clark via Histonet [mailto:histonet at lists.utsouthwestern.edu]
Sent: Monday, August 22, 2016 4:05 PM
To: histonet at lists.utsouthwestern.edu
Subject: [Histonet] CAP ANP.22970 Query

Hi Histonetters, we are wondering what everyone else out there is doing to be compliant with the following requirement?  We do ER and PR by IHC  but dont know what published benchmarks are out there to compare ourselves to.  Also, how do you record interobserver variability amongst the pathologists?  Any insights into this would be appreciated.

ANP.22970 Annual Result Comparison Phase II For immunohistochemical and FISH/ISH tests that provide independent predictive information, the laboratory at least annually compares its patient results with published benchmarks, and evaluates interobserver variability among the pathologists in the laboratory.
NOTE: Individuals interpreting the assay must also have their concordance compared with each other and this concordance should also be at least 95%.
With specific reference to estrogen and progesterone receptor studies: in general, the overall proportion of ER-negative breast cancers (invasive and DCIS) should not exceed 30%. The proportion is somewhat lower in postmenopausal than premenopausal women (approximately 20% vs. 35%). The proportion is considerably lower in well-differentiated carcinomas (<10%) and certain special types of invasive carcinomas (<10% in lobular, tubular, and mucinous types).
The proportion of PgR-negative cases is 10-15% higher than for ER-negative in each of these settings. Investigation is warranted if the proportion of negative cases is significantly lower in any of these settings.

Joanne Clark, HT
Director of Histology
Pathology Consultants of New Mexico
Roswell, New Mexico

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