The oncologic pathology report - Quality by design

Objective.-To review tenets of basic quality assurance and identify opportu nities for quality improvement in the laboratory assessment of prognostic f actors. Design.-College of American Pathologists Q-Probes data obtained from hundre ds of American laboratories throughout the 1990s are used to illustrate lab oratory performance and practice opportunities in the preanalytic, analytic , and postanalytic phases of the total testing process. Results.-A wide range of performance deficiencies are documented, most in t he preanalytic and postanalytic phases, and contributed by individuals outs ide and not under the control of the laboratory. In the analytic phase, the effectiveness of checklists on the content and completeness of reported di agnostic and prognostic data for breast and colon cancers is proven, Conclusions.-In the preanalytic phase, marked enhancements in quality would result from improvements in (1) patient and specimen identification, (2) a dherence to patient-sampling and specimen-handling requirements, and (3) co mmunication to the laboratory of the pertinent clinical context of the indi vidual test. Once basic analytic quality control and laboratory quality ass urance issues are resolved, a focus on standardization and enhancement of p reanalytic and postanalytic communications and satisfaction of clinical exp ectations becomes the source of improved laboratory performance.