Ann Lab Med.  2013 Nov;33(6):441-448. 10.3343/alm.2013.33.6.441.

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

• Hwang SH
• Jung SK
• Kang SJ
• Cha HS
• Chung SH
• Lee DH

• KMID: 1711318
• DOI: http://doi.org/10.3343/alm.2013.33.6.441

Abstract

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.

Keyword

Document management; Document identification code; Laboratory standardization; Clinical laboratory; Laboratory accreditation

MeSH Terms

Documentation/*standards
Hospitals, University
Laboratories, Hospital/*standards
Questionnaires
Tertiary Healthcare
User-Computer Interface

Figure

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  Fig. 1 Contents of the questionnaire used in this study.

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  Fig. 2 Schematic flow diagram of the Laboratory Medicine Document Management System (LMDMS). The document identification code in the header (in the present example, NCC-LMDM-EC01-1111) is extracted from the scanned file (WordPerfect file, WPF) (1). The image file is converted into a PDF file, which is stored on the document server (3), and the extracted document identification code and other document information (e.g., file tracking information) is stored on the database server (DB server) (2, 4).

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  Fig. 3 Screenshot of the document display system. Three different searching tabs are provided as ListView tab (file-name-oriented), TreeView tab (classification-oriented), and Document search tab, which is accessible for monthly query and search, and easy for browsing documents. The document (NCC-LMDM-EC01-1112) for daily temperature check of a refregerator of the diagnostic immunology division in our laboratory can be seen in the TreeView tab.

Reference

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2. Lee WG, Kwak YS, Lee DH, Hwang YS, Lee KN. Clinical pathology laboratory inspection and accreditation in Korea I: development of the system and its trial. Korean J Clin Pathol. 2001; 21:86–92.

3. Lee WG, Kwak YS, Lee DH, Hwang YS, Lee KN. Laboratory inspection and accreditation in Korea II: analysis of the first round inspection. Korean J Lab Med. 2003; 23:363–369.

4. Clinical and Laboratory Standards Institute. Laboratory documents: developement and control; Approved guideline. GP2-A5. 5th ed. Wayne, PA: Clinical and Laboratory Standards Institute;2006.