Control system for medical laboratory quality management system document and normalized control method thereof

Abstract

The invention discloses a control system for medical laboratory quality management system documents and a normalized control method thereof. The intelligent control system comprises a system parameter setting module, a system document parameter setting module, a file editing module, a file approving module, a document operation reminding module, a document referring module, a document reviewing module, a table compiling module, a record filling module and a record referring module. According to the control system for the medical laboratory quality management system documents and the normalized control method thereof provided by the invention, under the condition of meeting quality management standard, the compiling and alteration for the documents, the reviewing and approving for the documents, the referring and reviewing for the documents, the editing for record tables and the filling and reviewing for records can be realized in an informationized manner; simple operation is supported; the document conversion and the dynamic compiling of the record tables can be quickly realized; the quality system documents can be simply, efficiently and comprehensively controlled.

Description

technical field [0001] The invention relates to laboratory quality management standardization and information technology in the medical field, in particular to a control system and a standardized control method for medical laboratory quality management system documents. Background technique [0002] The International Organization for Standardization (ISO) issued the ISO15189 quality management standard in 2003, and the China National Accreditation Service for Conformity Assessment (CNAS) adopted this standard as the national standard in 2004. At present, domestic medical laboratories have generally established a quality management system, and many laboratories have passed or are applying for laboratory accreditation, mainly ISO15189 accreditation, and a few are CAP accreditation. Both ISO15189 and CAP standards are documented quality management systems. The primary task and premise of establishing a quality management system is to establish system documents (including record...

AI Technical Summary

Problems solved by technology

[0004] 1. High cost of document control: the laboratory needs to invest a lot of human, financial and material resources in the compilation, binding and management of documents

[0005] 2. The intensity and difficulty of document control work: document control vertically covers the entire life cycle of documents from creation to destruction, and horizontally involves people, machines, materials, methods, environment and quality events related to laboratory quality management. The workload is huge and Complicated, many tasks are difficult to complete by manual management alone

[0006] 3. Large waste of document control resources: There are many unavoidable mistakes in the document preparation process, and there are duplication of labor and multiple copies of the same document, resulting in waste of resources

[0007] 4. Document control efficiency is low: When writing documents, identification information such as identification number and version number must be prepared, and the layout of documents must be manually controlled; approval and release of documents must be repeatedly signed and stamped; it is not easy to obtain documents when using documents, and consulting document information takes up more time

[0008] 5. Document update is not timely: the document modification situation is complicated, the response method is difficult to unify, the process of document approval and release takes a long time, and the document update is often not timely, which is also one of the reasons for the wrong use of documents

[0009] 6. Misuse of documents often occurs: due to the simultaneous preservation of electronic documents, multiple controlled documents and abolished documents, there are also "transitional" documents, which may easily cause confusion and misuse

[0010] 7. Formalization of document training and review work: based on manually signed reading records and review records of record forms, it is difficult to track the learning and review of documents

[0011] 8. There are irregularities in record management: record files are generated by filling in forms manually, and there are behaviors such as "early filling, supplementary filling, modification, forgery and counterfeit signatures" when filling in records, making it difficult to ensure the requirements of "accurate, timely and complete" records

[0012] 9. Potential biological safety hazard: documents are often used or stored interspersed in the experimental area and office area, and the risk is easily overlooked by the staff

[0013] 2. Very few laboratories use self-built or commercialized software management system documents

[0014] 1. The function is limited and does not meet the requirements of quality management standards: it mainly realizes the centralized management of a single "complete electronic document" written by external software and has been "actually approved", that is, in a controlled state. It cannot uniformly control historical archive files, and does not involve file learning records and functions such as document review, and important functions such as writing or editing documents; the software does not understand the "quality system documents" enough, and fails to realize the control of record documents, that is, it cannot fully realize the "compilation and management of record forms, filling in records and consulting "Record" 3 basic functions

[0015] 2. The approval of documents is not standardized: they only carry out "post-registration approval" for documents that have been "actually approved", that is, controlled

[0016] 3. It is inconvenient to use files: you need to install client software or use third-party software to read files after downloading, and it does not support file search and file content search

[0017] 4. A small number of software has realized the file editing function, but there are: a. Using a mode similar to external Word editing to manually compile "complete electronic documents" containing various information, it is still necessary to additionally prepare file control information such as version number and identification number and control The layout, workload and difficulty of document writing have not improved compared with paper documents; b. There is no built-in document structure template, and the quality of document writing is uneven; c. The function of system version change is not supported, resulting in a huge amount of document transfer work

[0018] 5. A small number of software has realized the function of record file control, but there are: a. Compiling tables requires three complex operations: writing database tables, creating form templates, and setting tables. It is necessary to consider table numbers and layouts. It is very difficult to update tables, directly modify or create new ones Replacement will introduce new problems such as changes in reference records or numbering confusion; b. The preset content format of the form record items is not flexible when filling in the records; the previous information can be modified when filling in the form that needs to be filled multiple times, and the record filling is not standardized; c .Inspection records must be browsed one by one and search is not supported, which is not convenient enough

[0019] It can be seen that for medical laboratories, there is no standardized and practical solution for effective control of quality system documents.

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