QMP-LS News

IN THIS ISSUE

No. 126 May 2008

A new EQA Program: Immunohistochemistry for Breast Cancer Tumour Markers

Eye on OLA: Contract Review

Knowledge Transfer: Quality Management in Action - Call for submissions

NORONT's 30^th birthday in March 2008 a resounding success

Quali-TIP

Quality means doing it right when no one is looking.
~Henry Ford

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A new External Quality Assessment (EQA) Program: Immunohistochemistry for Breast Cancer Tumour Markers

by Jane Gun-Munro

QMP–LS will be conducting two pilot immunohistochemistry (IHC) surveys this month that allow performance assessment of all three breast tumour markers: estrogen receptor, progesterone receptor and Her2/neu protein.

Various national guidelines for screening of tumor markers in breast cancer, including

Canada, unanimously recommend the participation of laboratories in an external quality assessment program, to confirm acceptability of laboratory performance. Currently there is no such Canadian program available. QMP–LS has previously offered surveys for estrogen receptor on three occasions as part of its routine IHC program. However, currently we do not offer programs for progesterone receptor or Her2/neu protein. The pilot program is designed to assess all three markers simultaneously.

The pilot program will be issued to all eligible participants in Ontario as an addition to the routine pathology (PATH) survey. If the pilot surveys validate the proposed model, these surveys will be conducted three times a year, starting with the first routine surveys in July 2008 for Ontario laboratories.

These surveys will be offered nationally to laboratories in other Canadian provinces in November 2008.

Products and Services

The QMP–LS Anatomic Pathology survey is designed to evaluate laboratory performance in immunohistochemical (IHC) staining technique through assessment of stained tissue sections and also through patterns-of-practice surveys.

Surveys are designed to be clinically relevant, to reflect current scientific or medical issues important to health care and to support the quality improvement of laboratory services (see Features and Benefits). This model is not intended to assess the competence of individual laboratory professionals.

Features	Benefits
Program is offered three times a year	Three surveys per year provides sufficient challenge for a realistic assessment of on-going laboratory performance
Program assesses all three markers	A challenge of all markers at the same time using the similar criteria provides convenient, reliable and consistent assessment of performance
Macro array of tissue or cell blocks provided for each marker	Use of macro arrays enables use of material with different levels of expression, providing an assessment of the full dynamic range of staining Cell blocks for Her2/neu confirmed by FISH
Negative control provided for each marker	This provides information on optimization and cross-reactivity of reagents
Duplicate slides for each stain will be provided	Laboratories have sufficient material for repeating the process, should a problem with staining occur
Predefined criteria established for staining of each marker	Criteria define key aspects of staining process and performance of immunohistochemistry reagents
A panel of trained pathologists and histotechnologists review all returned slides	Peer review by a panel of experts in the field against predefined criteria assures objective assessment
Performance assessment is based on weighted criteria	Weighted criteria emphasize performance assessment on most critical components of assay
Survey report provides a score for each criterion	Report identifies opportunities for improvement of immunohistochemistry reagents and staining process. Unsatisfactory scores prompt cause analysis and implementation of corrective action
Cumulative survey reports provide a summary of performance over time	Cumulative performance demonstrates consistency in laboratory processes and effectiveness of corrective action for areas requiring improvement
Comprehensive educational comments summarize and critique participant performance	A critique of performance provides all participants with the opportunity to learn about the reasons for successful performance, as well as the issues contributing to poor performance
Coloured photomicrographs of reference and participant stains are provided	A picture is worth a thousand words in identifying the good, bad and ugly stains

The cost per survey will be available on request. For more information on these new products, please contact Joanne Miyazaki at 416.323.9540 ext. 241 or e-mail .

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