The framework of pathology: good laboratory practice by quantitative and molecular methods.

Combined confocal laser scan microscopy (CLSM) and Fourier analysis (FA) by non-pathologists of dermal collagen bundle orientation recently gave results superior to subjective evaluation by experts. According to Good Laboratory Practice (GLP) criteria, combined CLSM/FA has not yet been adequately tested to replace current collagen evaluation, but this will not take long. Non-pathologists (clinicians) will then have taken over a laboratory test historically belonging to pathology. A general trend in this direction may develop, because pathologists seem not always to care enough about clinical significance, reproducibility and prognostic value, and new demands for innovative methods. Quantitative image analysis (QIA) and molecular methods are reproducible, inexpensive, and easy to perform; they often have greater value than classical evaluations and their cost-benefit ratio is good. However, their acceptance is not as widespread as one would expect and theoretical reasons which have been advanced do not provide a satisfactory explanation. A formal implementation study was therefore performed, in which an attempt was made to modernize a classical pathology laboratory. An external customer satisfaction investigation showed that 96% of the clinicians were 'very satisfied' (the highest rating possible) with the completed innovations, contrasting with low satisfaction at the beginning. Lack of primary innovative leadership among pathologists was judged to be the dominant cause preventing implementation. Pathologists should focus on carefully reacting to new clinical needs, using GLP criteria. Reproducibility and predictive accuracy should be major themes in any pathology practice. Copyright 2002 John Wiley & Sons, Ltd.