Development of a document management system for the standardization of clinical laboratory documents

Documentation is very important; a considerable number of documents exist for use in accreditation inspection. However, most laboratories do not effectively manage the processes of documentation, organization, and storage. The purpose of this study was to facilitate the establishment of a strategically effective and sustainably standardized document management system.

A document code formatting system was modified by comparing the document list data received from 3 major university hospitals. In addition, a questionnaire regarding document code standardization was created and sent to 268 institutes to establish document classifications and generate a standard coding scheme. A computerized document management system was developed.

Only 32% (8 out of 25 institutes) answered that they were able to identify all of the document types and their numbers. In total, 76% of institutes (19 out of 25) answered that a systematic document management system was necessary. Disorganized document files were systemized by classifying them into 8 major groups according to their characteristics: patient test records (T), test quality control (Q), manuals (M), equipment and environment management (E), statistics (S), division administration (A), department administration (R), and others (X).

Our documentation system may serve as a basis for the standardization of documents and the creation of a document management system for all hospital laboratories.