PMID- 26412217
OWN - NLM
STAT- MEDLINE
DCOM- 20160223
LR  - 20151117
IS  - 1532-8392 (Electronic)
IS  - 0046-8177 (Linking)
VI  - 46
IP  - 12
DP  - 2015 Dec
TI  - Institutional quality assurance for breast cancer HER2 immunohistochemical 
      testing: identification of outlier results and impact of simultaneous 
      fluorescence in situ hybridization cotesting.
PG  - 1842-9
LID - S0046-8177(15)00305-6 [pii]
LID - 10.1016/j.humpath.2015.08.001 [doi]
AB  - The College of American Pathologists Accreditation Checklist requires comparison 
      of laboratory predictive results with published benchmarks but does not require 
      analysis of individual pathologists. With the availability of targeted human 
      epidermal growth factor receptor 2 (HER2) protein therapy, uniform reporting of 
      HER2 protein status by immunohistochemistry (IHC) is essential. Our aim was to 
      compare HER2 IHC results among pathologists in routine clinical practice within a 
      single institution and assess the impact of simultaneous IHC and fluorescence in 
      situ hybridization (FISH) ordering. We reviewed reports from 928 consecutive 
      breast needle biopsies from 2008 to 2012 at a tertiary academic medical center in 
      which HER2 IHC and HER2 FISH were ordered. There was a significant association 
      between breast pathologist and IHC result (negative, 49.8%-83.2%; positive, 
      8.7%-14.1%; equivocal, 5.2%-41.5%; P < .0001) but not breast pathologist and FISH 
      result (P = .69). For 1 pathologist, IHC signed out with FISH had an equivocal 
      rate nearly 2-fold lower than IHC results that were reported first (10.5% versus 
      20.9%) (P = .04). Institutions should be aware that although overall HER2 IHC 
      reporting may be consistent with guidelines, there can be significant variation 
      among practitioners. In addition to aggregate data, we recommend comparing the 
      rates from individual pathologists to standards. Furthermore, routine 
      simultaneous ordering of both IHC and FISH could impact interpretation of test 
      results and may inappropriately encourage less confidence in IHC results among 
      pathologists.
CI  - Copyright (c) 2015 Elsevier Inc. All rights reserved.
FAU - Green, Ian F
AU  - Green IF
AD  - Department of Pathology, The Ohio State University Medical Center, Columbus, OH 
      43210.
FAU - Zynger, Debra L
AU  - Zynger DL
AD  - Department of Pathology, The Ohio State University Medical Center, Columbus, OH 
      43210. Electronic address: debra.zynger@osumc.edu.
LA  - eng
PT  - Journal Article
DEP - 20150822
PL  - United States
TA  - Hum Pathol
JT  - Human pathology
JID - 9421547
RN  - 0 (Biomarkers, Tumor)
RN  - EC 2.7.10.1 (ERBB2 protein, human)
RN  - EC 2.7.10.1 (Receptor, ErbB-2)
SB  - IM
MH  - Biomarkers, Tumor/analysis
MH  - Biopsy, Large-Core Needle
MH  - Breast Neoplasms/*genetics
MH  - Female
MH  - Humans
MH  - Immunohistochemistry/*standards
MH  - In Situ Hybridization, Fluorescence
MH  - Male
MH  - Middle Aged
MH  - Observer Variation
MH  - Pathology, Clinical/*standards
MH  - *Quality Assurance, Health Care
MH  - Receptor, ErbB-2/*analysis
OTO - NOTNLM
OT  - Breast cancer
OT  - FISH
OT  - HER2
OT  - IHC
OT  - Quality assurance
EDAT- 2015/09/29 06:00
MHDA- 2016/02/26 06:00
CRDT- 2015/09/29 06:00
PHST- 2015/03/15 00:00 [received]
PHST- 2015/08/02 00:00 [revised]
PHST- 2015/08/13 00:00 [accepted]
PHST- 2015/09/29 06:00 [entrez]
PHST- 2015/09/29 06:00 [pubmed]
PHST- 2016/02/26 06:00 [medline]
AID - S0046-8177(15)00305-6 [pii]
AID - 10.1016/j.humpath.2015.08.001 [doi]
PST - ppublish
SO  - Hum Pathol. 2015 Dec;46(12):1842-9. doi: 10.1016/j.humpath.2015.08.001. Epub 2015 
      Aug 22.