Traceability in Anatomic Pathology – Recommendations and Best Practices.

Abstract

INTRODUCTION

Traceability in pathological anatomy is increasingly a requirement related to the clinical risk that derives from its lack. The SIAPEC guideline of May 2015 suggests its application in Pathological Anatomies but does not codify the requirements for which software companies develop and issue traceability forms in the absence of mandatory requirements.

METHODS

By applying the “Lean Six-Sigma” methodology we have redesigned the pathological anatomy process, correctly identifying where traceability can be the added value for both the patient and the operators.

OBJECTIVES

The aim of the study is to analyze the flows of pathological anatomy processes to be traced using the Lean methodology and develop a best practice to guide their application.

RESULTS

The “Value Stream Map” and the analysis of the data collected made it possible to correctly identify the traceability points (track) to be implemented throughout the sample process in the laboratory to guarantee the safety of the process with the identification of upstream feedback (phase pre-preanalytical) and downstream (phase post-post analytical) of two moments of interface with the external user to guarantee the effectiveness of the process.

DISCUSSION

The inclusion of a traceability system within the pathological anatomy processes is, especially in centers with a high density of activity, a mandatory requirement. Correctly identifying the essential points to be traced, through the application of the “value stream map”, avoids the redundancy of surveys by operators which are often the primary cause of refusal to insert a tracking system.

CONCLUSIONS

The Lean methodology, with the "value stream map" tool, allows operators to be able to correctly map the health processes. Following a correct evaluation of the process, it is possible to identify areas for improvement and redesign a new process with more added value.