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| Analysis of on-site quality inspection results of laboratories of the free pre-pregnancy physical examination project in Jiangsu Province |
| Jiangsu Health Development Research Center, NHC Contraceptives Adverse Reaction Surveillance Center, Nanjing, Jiangsu Province, 210036 |
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Abstract To analyze the results of on-site quality inspection of laboratories of the free pre-pregnancy physical examination project in Jiangsu Province, and to provide evidences and suggestions for continuously improving the quality management level and technical service capacity of project laboratories. Methods: A total 64 laboratories were selected as the objects of the on-site quality inspection from 99 service institutions that carried out the national free pre-pregnancy physical examination project in Jiangsu Province. Comprehensive evaluation on professional quality, equipment performance, testing project development, quality management documents, internal quality control, and external quality assessment were carried out by means of on-site inspection, document consulting, onsite communication, and questionnaire survey. Results: Most laboratories had established relatively perfect quality management system, which could meet the needs of standardized development of national free pre-pregnancy physical examination project. The proportions of the laboratories instrument with planning and the formulated SOP of test items were 90.6% and 76.6%, the proportions of laboratories with management documents about before, during, and after analysis and instrument used management records were 75.0% and 62.5%, and the proportions of laboratories with standardize internal quality control and actively participated in the external quality assessment organized by the inspection center were 60.9% and 81.3%. However, there were still some problems in the quality management, such as unstandardized internal quality controlling, lack of equipment calibration records, and the low participation rate of quality management training, the proportions of which were 39.1%, 36.5%, and 55.4%, respectively. Conclusion: The clinical test quality of the laboratories in the national free pre-pregnancy physical examination in Jiangsu province is generally good, but there are still some problems. So, the supervision of laboratories should be further strengthened, and the quality of clinical test of the relevant units should be urged to continuously improve in the later work.
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