Original Article

Ann Lab Med 2013; 33(6): 441-448

Published online November 1, 2013

Copyright © Korean Society for Laboratory Medicine.

Development of a Document Management System for the Standardization of Clinical Laboratory Documents

Sang-Hyun Hwang, M.D.1, Seon-Kyung Jung, M.D.1, Soo-Jin Kang, M.T.1, Hyo Soung Cha, M.S.2, Seung Hyun Chung, M.D.3, and Do-Hoon Lee, M.D.1

Department of Laboratory Medicine, Center for Diagnostic Oncology1, Department of Information Technology Team2, Rehabilitation Clinic, Center for Clinical Specialty3, National Cancer Center, Goyang, Korea

Correspondence to: Do-Hoon Lee
Department of Laboratory Medicine, Center for Diagnostic Oncology, National Cancer Center, 323 Ilsan-ro, Ilsandong-gu, Goyang 410-769, Korea
Tel: +82-31-920-1734
Fax: +82-31-920-1339

Received: February 25, 2013; Revised: May 14, 2013; Accepted: July 9, 2013

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.


Background: 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. Methods: 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. Results: 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). Conclusions: 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.

Keywords: Document management, Document identification code, Laboratory standardization, Clinical laboratory, Laboratory accreditation