About CQPath

Tests are performed within pathology (1) to increase patient life expectancy by providing a more accurate diagnosis, thereby leading to more appropriate therapy; (2) to increase diagnostic certainty, and to predict patient prognosis; and (3) to increase ability to predict patient outcome (regardless of treatment).

Although pathologists and lab technicians work to the best of their ability, they are facing the challenge of false negative and false positive tests. Because:

  • Due to false negative tests, patients may not receive the right treatment, or receive no treatment at all. An article in The Wall Street Journal of January 2008 states that, as a result of false negative tests performed in pathology laboratories, thousands of women with breast cancer did not receive the right treatment.
  • False negative or false positive lab tests may lead to a false diagnosis and participation or non-participation of these patients in clinical trials may influence the outcome of a study.
  • Due to inter-laboratory variation prognostic tests are losing their potential and cannot be used.

A couple of years ago the Pathology lab of Daniel den Hoed-Erasmus MC started a project with the goal improving the reliability of pathology tests. At first immunohistochemistry was improved by daily monitoring of specificity, sensitivity and monthly monitoring reproducibility. This lead to increased patient care, increased conficdence within the Pathology department and a decrease of test costs by less defects and aimed troubleshooting. For the ISO15189 Accreditation in the near future we also needed QA/QC records. Our approach proved successful in reaching all these goals.

For this project we used the DMAIC (define, measure, analyze, improve, control) approach.

By following the recommendation of the biological Stain commission (University of Rochester Medical Center, Rochester, NY), NORDIQC and several authors we used control tissue with low levels of target antigen; to ensure that the stain system has the sensitivity to stain low antigen levels and reduce the risk of false-negative results. From the authorized (authorization is determined by literature research, by studying results of External Quality Programmes and by the experience of experts in the field) staining we made a picture and we defined this picture and the description of the staining result as the Reference. The Reference was made easy accessible in a web based IT tool.

By monitoring the daily quality (validation of the control slides on the basis of the references= control) we could minimize the risk of interpretation of false negative and false positive tests by pathologists.

Because the process of pathology tests is technically complex and several critical parameters may influence the test result we developed an IT tool (CQPath-TQM) in which the result of the control (score) is linked to several critical parameters of the process flow. Test failures could be found by clicking a button and by queries.

By using the References in combination with the CQPath-TQM we could measure the defects and analyze the QC/QA records. We were also able to improve the quality of process outputs (IHC-tests) by identifying and removing the causes of defects (errors) and minimize the variability in the process.

This and the involvement of our total staff resulted in less defects, resulting in higher patient safety and lower costs.

Try the References and score your test results. With sharing your findings with the CQPath project, you help establish and improve a world-class set of references, which can help to increase the reliability of pathology tests.

The CQPath project has the goal to establish a world-class set of references and a quality management approach for every pathology test.