| Objective:Regional medical laboratory has become a trend in the development of clinical laboratories,and establishing and running quality management systems in accordance with international standards to implement total quality management has become a common requirement.There are many difficulties and shortcomings in using manual methods or single application of LIS for quality management.The laboratory quality management system designed and established based on the ISO15189 quality management standard has gradually been applied and achieved good results.This study aims to establish and evaluate a regional medical laboratory quality management intelligent platform.Methods:First,redesign the pre-built quality management system for clinical laboratory,mainly adding support total involvement in integration management of multi-site and multi-level laboratories,while improving other designs;revise the source code and database,and then deploy the system to a cloud server to establish a clinical laboratory quality management cloud system.Second,aim at the weakness in each link of the regional test process from test order to results interpretation,design an intelligent transformation schema for regional test processes by introducing new technological equipment,developing new platform or functions,and transforming existing equipment,systems,and processes,then make every effort to make the schema implementation.Third,integrate the established software and hardware mentioned above to form a regional medical laboratory quality management intelligent platform,and evaluate its application effectiveness.Results:(1)Through the renovation design and redevelopment of the self built system in the early stage,a clinical laboratory quality management cloud system has been established to achieve intelligent management functions for organizational structure,personnel,equipment,service supply,documents,records,environmental monitoring,consulting services,and performance evaluation.Support the establishment and running of the ISO15189 quality management system in multi-site and multi-level laboratories using the same system,and support total involved in laboratory quality management(2)The expected transformation goal of the scheme has been achieved by over 75%,and the functions has basically covered the internal test process management of the hospital.(3)Clinical application evaluation:After the platform is applied in clinical practice,the system document version change has been reduced from 45 days for 30 people to 15 days for 15 people to complete,it significantly reducing work intensity;reducing the time required to access documents,prepare tables,and access records from 16 minutes,30 minutes,and 15 minutes to 5 minutes,8 minutes,and 1 minute,respectively,it significantly improving work efficiency;Cost savings can be achieved by saving 75000 yuan annually in office consumables for documents,records,and training exams;Improved satisfaction among all parties,with employee,medical staff,and patient satisfaction increasing from 95%,94%,and 95%to 98%,98%,and 97%respectively;The quality of specimens has been improved,and the incidence of unqualified specimens has decreased from 0.32 ‰ to 0.21 ‰;The report TAT has been shortened,and the median specimens collection-receiving time has decreased from 45 minutes to 34 minutes;Conclusion:The regional medical laboratory quality management intelligent platform has achieved excellent performance and has the potential to become a more powerful and perfect quality management solution and will be applied in regional laboratories in the future.This study has completed a prospective work on regional laboratory quality management solutions,which is also of great significance for improving the current level of laboratory quality management,automation,and intelligence. |
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