Laboratory medicine is the fastest growing among all specialized medical fields in terms of the development and introduction of new medical technologies. Recently, there have been growing needs to standardize medical laboratory test results in various areas of laboratory medicine and establish a standardized global system that is applicable across all fields of medical laboratory science.

In the United States, the College of American Pathologists (CAP) has implemented a laboratory standardization and accreditation system since 1962 and has continued to improve laboratories' quality through program development and improvement of its accreditation systems [1]. In Korea, accrediting evaluations and accreditations through the Korean Laboratory Accreditation Program (KLAP) were started in 1999 in order to improve the quality, accuracy, and reliability of laboratory work [2, 3]. At present, 268 laboratories participate in the KLAP. This allows for the systematic implementation of external and internal clinical laboratory quality assurance; quality control of safety, human resources, and equipment management; and laboratory standardization.

The KLAP inspection checklists were developed by considering domestic situations and referring to various foreign accreditation programs, including that of the CAP; they comprise 1,539 questions divided into 12 areas, including laboratory management [2, 3]. Each area consists of sub-items covering external quality assessment, quality improvement, internal quality control, laboratory test management by field, personnel, physical facilities, and laboratory safety. The checklist items regarding laboratory management include ones on specimen collection and handling, water quality control, glassware washing, assessment of laboratory skills, and laboratory computer services. Scores are given to these items, and revisions are made annually, including corrections and updates.

Documentation is very important in most cases, and a considerable number of documents exist for the purpose of accreditation inspection. However, most laboratories do not effectively manage the processes of documentation, organization, and storage; even within a single laboratory, document titles and formats vary among content areas. To improve this, a standard regulation that governs document management systems was recently added to the KLAP inspection checklist for laboratory management (01.201.380: "Is there a document management system?"). However, each hospital laboratory has only this item in its handbook and lacks concrete methods and detailed regulations for standardization; this only worsens existing within-laboratory confusion, which may create problems with inter-laboratory communication and information compatibility. Ineffective database management may even lead to financial losses; therefore, the systematic and practical management of document management systems through the process of document code standardization will greatly improve quality in the field of laboratory medicine.

The CAP has also expressed the need for document management as part of its Laboratory Accreditation Program. Although the CLSI guideline describes general principles of documentation management in CLSI document GP2-A5 [4], there are presently no detailed regulations or guidelines regarding document code standardization-not even in pertinent international guidelines. The laboratory general checklist of the 2010 CAP accreditation program has an item, GEN.20375 document control, which is intended to check whether a document control system exists.

The purpose of this study was to facilitate the establishment of a strategically effective and sustainably standardized document management system by developing methods for document classification and document code standardization in order to improve the quality of laboratory medicine in the medical laboratories of domestic hospitals.

The results of the questionnaire survey revealed that most institutes consider document standardization to be very important. Furthermore, these results confirmed the importance of interdepartmental and inter-hospital standardization of document titles, justifying the objective of the present study. The inspection checklist currently applied to the KLAP accreditation inspection comprises over 1,500 items spanning 12 areas. Documentation is essential for the inspection. To date, hospital laboratories have created various types of documents according to their needs without abiding by any set regulations. Prior to standardization, we gathered laboratory directors' opinions on the necessity of a document control system and standardization thereof. The results confirmed the urgent need for a systematic and standardized document management system. Among the institutes answering that document management was practiced, only 32% of interviewees (8 out of 25) answered that they could identify the document types and their numbers. This means that the laboratory documents prepared for accreditation inspections were not managed properly in most institutes. However, 40% of the institutes had document system manuals and gave their documents unique identification numbers. In addition, 95.2% recognized that the same types of documents had different titles in different sections within the same laboratory and highlighted the necessity of standardization of document titling.

The GP-A5 guideline of CLSI presents the important components of procedure writing and management for clinical laboratories, especially those focused on the development of laboratory procedures [4]. Our study focused on standardization of document identification, and we presented the implementation of a document management system with our scheme. We propose a method of systemizing disorganized document files by classifying them according to their characteristics into 8 major groups: files and documents belonging to each major group were then organized into sub-major groups and given appropriate codes. In addition to this coding scheme, file and document titling were standardized through unification of the designations used by different departments. This enables systematic document management and provides a basic framework for compatibility in document exchange among hospitals.

Towards the beginning of the study, serial numbers of 2 or more digits were assigned to the documents; however, this practice was discontinued, because many documents did not use serial numbers. Furthermore, version-based management was not addressed because of its lack of practical relevance. The letters "I" and "O" were excluded from the coding scheme to prevent confusion with "one" and "zero," respectively, and any resulting computerization errors. Reagent evaluation had too many items to differentiate by document codes alone. Such criteria and classifications will frequently be useful in the future generation and organization of various documents. If hospital laboratories nationwide adopt such a systematic and effective system of document code standardization, the efficacy and convenience of communication within and among laboratories will be enhanced; thus, quality improvement in the field of laboratory medicine will be facilitated.

Our standardized documents can be managed electronically. Our institution scans documents and files after 2 yr storage; the scanned items are automatically converted into PDF files and stored automatically according to their assigned codes. The electronic system also enables review and retrieval by keyword, time period, and index.

Herein, we provide a basic framework to facilitate the systematic classification and management of various documents that serve as evidence in initiatives taken by each laboratory to assure accurate test results and quality improvement, which are the main inspection targets for accreditation. Besides its utility for onsite inspection, such standardization of document classification and coding will also enable systematic management and review and contribute to effective quality control in laboratories. Our document management system made periodic review of documents possible with reasonable effort.

The document management system should include processes of document identification, timely review and approval of both new and formerly approved documents, and retention and discarding of documents [4]. Especially, management of timely review and approval of formerly approved documents is very important.

One limitation of this study was that our results were not compliant with the International Organization for Standardization (ISO); further, the terms described in this study did not fully match CLSI terms, because the identification codes originated from document types in Korean laboratories whose situations do not seem identical with those of laboratories in the United States. Our study was not implemented in other hospitals. Thus, further efforts are necessary to generalize our document identification scheme.