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The 2010 ASCO/CAP guideline recommendations for immunohistochemical testing of estrogen (ER) and progesterone (PgR) receptors in breast cancer suggest that laboratories enact a quality management program encompassing all aspects of testing. With regard to the analytic phase of testing, the guideline suggests periodic trend analysis to confirm an appropriate number of ER-positive breast cancers in the patient population served by the laboratory.

Enrollment in QP193 will assist participating laboratories in comparing their predictive marker results with those of other laboratories, and address compliance with CAP Laboratory Accreditation Program Checklist statement ANP.22970, annual result comparison of immunohistochemical tests performed on invasive breast carcinoma specimens.


This study aims to compare invasive breast cancer expression rates for ER, PgR, and HER2 with those of other laboratories. Expression rates will be stratified by histologic type and patient age, where applicable, to provide participants further insight into this analytic phase of immunohistochemical testing.

Data Collection

During a one-month period, participants will provide ER, PgR, and HER2 test results from all invasive breast cancer cases. Other case-specific factors will be collected including patient age, histologic tumor type, method of assessment, tumor grade, and tissue type.

Participants will also provide institution level ER/PgR positive rates, and HER2 2+ and 3+ result rates from the previous calendar year or most recent annual data aggregation.

Information regarding general practices involved in expression testing will be collected, such as antibody clones used in testing.

Performance Indicators

  • ER positive rate (%)
  • PgR positive rate (%)
  • HER2 score 2+ rate (%)
  • HER2 score 3+ rate (%)

Shipping Schedule

C Mailing: June 10, 2019

Additional Information

This is a one-time study conducted in the third quarter.

Q-PROBES qualify for Self-Reported Training Opportunities to be used for fulfilling requirements for certification maintenance by agencies such as the American Society for Clinical Pathology (ASCP). Please verify with your certifying agency to determine your education requirements.

For Comprehensive Collection of Tools, see Quality Management Tools.

Select Q-PROBES and Q-TRACKS studies to support your quality improvement initiatives.
Anatomic Pathology
Clinical Pathology
Turnaround Time
Patient Safety
Transfusion Medicine
Chemistry/ Hematology
Customer Satisfaction
Technical Staffing Ratios (QP191)
Opioid Drug Testing Stewardship (QP192)
Expression Rates in Invasive Breast Carcinoma (QP193)
The Impact of Pathologist Review on Peripheral Blood Smears (QP194)
Patient Identification Accuracy (QT1)
Blood Culture Contamination (QT2)
Laboratory Specimen Acceptability (QT3)
In-Date Blood Product Wastage (QT4)
Gynecologic Cytology Outcomes: Biopsy Correlation Performance (QT5)
Satisfaction With Outpatient Specimen Collection (QT7)
Stat Test Turnaround Time Outliers (QT8)
Critical Values Reporting (QT10)
Troponin Turnaround Times (QT15)
Corrected Results (QT16)
Outpatient Order Entry Errors (QT17)

*The CAP requires accredited laboratories to have a quality management plan that covers all areas of the laboratory and includes benchmarking key measures of laboratory performance (GEN.13806, GEN.20316, COM.04000). The Joint Commission requires accredited hospitals to regularly collect and analyze performance data (PI.01.01.01, PI.02.01.01). CLIA requires laboratories to monitor, assess, and correct problems identified in preanalytic, analytic, and postanalytic systems (§493.1249, §493.1289, §493.1299).